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6 jobs found in middletown, new jersey

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    • new york, new york (remote)
    • temp to perm
    • $25 - $29 per hour
    Exciting Work from Home Role- Equipment Included!!! Federally Aligned Account Paid Weekly: Please include salary requirements in resume.    Hours of Operation: East Coast Hours: 8:00 am - 5:00 pm; needs to be flexible based on client’s location    Implementation Specialist - Position Summary: The primary responsibility of the Implementation Specialist is to coordinate the onboarding activities of new clients. The position works in partnership with Company Departments to coordinate resources and effectively implement the Company’s products and services in accordance with the client’s business needs. The Implementation Specialist works both collaboratively and independently with new clients and Company departments to ensure a successful onboarding experience and timely delivery of commitments.  salary: $25 - $29 per hourshift: Firstwork hours: 8 AM - 5 PMeducation: BachelorResponsibilitiesPrimary point of contact for new clients during implementation process to recommend/negotiate strategic timelines as it relates to service and product deliverables •          Identify client needs and determine how new clients will use the Company’s products and services •          Develop implementation plans that strategically enhance the client’s onboarding experience while staying aligned with the Company’s standard operating procedures and contractual obligations of the client and the Company •          Educate clients on the Company’s policies and practices •          Ensure client satisfaction throughout the onboarding process, including successful handoff of client to internal support team •          Manage communication with client and internal Company resources to ensure a smooth and successful onboarding experience for clients, while keeping within targeting completion deadlines •          Deliver training webinars to clients on our products SkillsHRISSHRM-CP (3 years of experience is preferred)PHR (3 years of experience is preferred)SPHR (3 years of experience is preferred)Employee Relations (1 year of experience is preferred)Project Management (1 year of experience is preferred)Performance ManagementTraining (2 years of experience is preferred)Human ResourcesOrganizational SkillsHandling Confidential InformationVerbal CommunicationBasic Software SkillsMicrosoft Office (3 years of experience is preferred)ADP-HRHRMSSchedulingTechnicalCustomer ServicecollaborationClient ServiceAccount ManagementCommunicationQualificationsYears of experience: 3 yearsExperience level: ExperiencedRandstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    Exciting Work from Home Role- Equipment Included!!! Federally Aligned Account Paid Weekly: Please include salary requirements in resume.    Hours of Operation: East Coast Hours: 8:00 am - 5:00 pm; needs to be flexible based on client’s location    Implementation Specialist - Position Summary: The primary responsibility of the Implementation Specialist is to coordinate the onboarding activities of new clients. The position works in partnership with Company Departments to coordinate resources and effectively implement the Company’s products and services in accordance with the client’s business needs. The Implementation Specialist works both collaboratively and independently with new clients and Company departments to ensure a successful onboarding experience and timely delivery of commitments.  salary: $25 - $29 per hourshift: Firstwork hours: 8 AM - 5 PMeducation: BachelorResponsibilitiesPrimary point of contact for new clients during implementation process to recommend/negotiate strategic timelines as it relates to service and product deliverables •          Identify client needs and determine how new clients will use the Company’s products and services •          Develop implementation plans that strategically enhance the client’s onboarding experience while staying aligned with the Company’s standard operating procedures and contractual obligations of the client and the Company •          Educate clients on the Company’s policies and practices •          Ensure client satisfaction throughout the onboarding process, including successful handoff of client to internal support team •          Manage communication with client and internal Company resources to ensure a smooth and successful onboarding experience for clients, while keeping within targeting completion deadlines •          Deliver training webinars to clients on our products SkillsHRISSHRM-CP (3 years of experience is preferred)PHR (3 years of experience is preferred)SPHR (3 years of experience is preferred)Employee Relations (1 year of experience is preferred)Project Management (1 year of experience is preferred)Performance ManagementTraining (2 years of experience is preferred)Human ResourcesOrganizational SkillsHandling Confidential InformationVerbal CommunicationBasic Software SkillsMicrosoft Office (3 years of experience is preferred)ADP-HRHRMSSchedulingTechnicalCustomer ServicecollaborationClient ServiceAccount ManagementCommunicationQualificationsYears of experience: 3 yearsExperience level: ExperiencedRandstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • edison, new jersey (remote)
    • temporary
    • $35 per hour
    Are you looking for the next steps in your project management career? We are looking for a solution-oriented Project Manager that will be based remotely for our healthcare services client. The ideal candidate has at least 2 years of Project Management experience, with a demonstrated track record of gathering requirements from various stakeholders, synthesizing information and creating actionable project plans with detailed tasks, ownership, timelines and dependencies. We are looking for a positive, self-starter with exceptional collaboration and communication skills.  salary: $35 - $35 per hourshift: Firstwork hours: 8 AM - 5 PMeducation: BachelorResponsibilitiesThe Project Manager provides a high level of accountability and ownership, making demonstrable contributions to project vision, achieving a high level of collaboration with colleagues and stakeholders, and ensuring that projects are meeting or exceeding expectations and timelines. The Project Manager works with internal stakeholders to define project need and create detailed documentation that will be used to guide scope for the Client Relations team. They are responsible for managing long and short term projects, providing tracking/reporting on the project’s progress against planned milestones. Deploy consistent, disciplined and effective project management processes for prioritized projects roadmap Accountable for the on-time Implementation of new Health Plans, new lines of business, and new states Develop and implement processes and procedures for effective and efficient project implementation SkillsProject ManagerProject Management ProfessionalAgileScrumSix SigmaOperationsDecision MakingPrioritizingOrganizationCommunicationAnalysisCoordinationQualificationsYears of experience: 2 yearsExperience level: ExperiencedRandstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    Are you looking for the next steps in your project management career? We are looking for a solution-oriented Project Manager that will be based remotely for our healthcare services client. The ideal candidate has at least 2 years of Project Management experience, with a demonstrated track record of gathering requirements from various stakeholders, synthesizing information and creating actionable project plans with detailed tasks, ownership, timelines and dependencies. We are looking for a positive, self-starter with exceptional collaboration and communication skills.  salary: $35 - $35 per hourshift: Firstwork hours: 8 AM - 5 PMeducation: BachelorResponsibilitiesThe Project Manager provides a high level of accountability and ownership, making demonstrable contributions to project vision, achieving a high level of collaboration with colleagues and stakeholders, and ensuring that projects are meeting or exceeding expectations and timelines. The Project Manager works with internal stakeholders to define project need and create detailed documentation that will be used to guide scope for the Client Relations team. They are responsible for managing long and short term projects, providing tracking/reporting on the project’s progress against planned milestones. Deploy consistent, disciplined and effective project management processes for prioritized projects roadmap Accountable for the on-time Implementation of new Health Plans, new lines of business, and new states Develop and implement processes and procedures for effective and efficient project implementation SkillsProject ManagerProject Management ProfessionalAgileScrumSix SigmaOperationsDecision MakingPrioritizingOrganizationCommunicationAnalysisCoordinationQualificationsYears of experience: 2 yearsExperience level: ExperiencedRandstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • new york, new york (remote)
    • temporary
    • $66.21 - $71.21 per hour
    Looking for a Communications Manager to join the Feed and Communities communications team for an app. This individual will work closely with product and partnerships teams to support the development of strategic campaigns and proactive product moments that communicate the value the App delivers to communities. We’re seeking a candidate with strong project management skills who possesses some external communications experience working with technology, business and consumer media. Approved Remote Locations: Baltimore, MD, Boston, MA, Houston, TX, Los Angeles, CA, and San Diego, CA. Minimum Qualifications Bachelors Degree in Journalism, Political Science, Communications or related field 3+ years of work experience in external communications or media relations Experience with media relations across technology, business and consumer publications Experience working with company leaders and executives salary: $66.21 - $71.21 per hourshift: Firstwork hours: 8 AM - 5 PMeducation: BachelorResponsibilitiesSupport the Facebook App product comms team with a focus on community and monetization products, and community partnerships Support the development of strategic campaigns and proactive product moments that communicate the value the Facebook App delivers for communities and their members Develop messaging for blog posts, executive briefing docs, press statements, social posts, etc. Proactive creative storytelling -- from ideation to execution -- across several product areas Manage multiple projects simultaneously across and work cross-functionally with partners like marketing, product, partnerships, policy, legal, privacy, and international PR teams Identify trends and opportunities to amplify our community products and community storytelling around cultural moments Build relationships with media, press, influencers, and other external stakeholders Work closely with external PR agency Work autonomously and as part of a cross-functional team in a fast-paced environmentSkillsMarketing Communicationsexternal communicationsmedia relationsQualificationsYears of experience: 3 yearsExperience level: ExperiencedRandstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    Looking for a Communications Manager to join the Feed and Communities communications team for an app. This individual will work closely with product and partnerships teams to support the development of strategic campaigns and proactive product moments that communicate the value the App delivers to communities. We’re seeking a candidate with strong project management skills who possesses some external communications experience working with technology, business and consumer media. Approved Remote Locations: Baltimore, MD, Boston, MA, Houston, TX, Los Angeles, CA, and San Diego, CA. Minimum Qualifications Bachelors Degree in Journalism, Political Science, Communications or related field 3+ years of work experience in external communications or media relations Experience with media relations across technology, business and consumer publications Experience working with company leaders and executives salary: $66.21 - $71.21 per hourshift: Firstwork hours: 8 AM - 5 PMeducation: BachelorResponsibilitiesSupport the Facebook App product comms team with a focus on community and monetization products, and community partnerships Support the development of strategic campaigns and proactive product moments that communicate the value the Facebook App delivers for communities and their members Develop messaging for blog posts, executive briefing docs, press statements, social posts, etc. Proactive creative storytelling -- from ideation to execution -- across several product areas Manage multiple projects simultaneously across and work cross-functionally with partners like marketing, product, partnerships, policy, legal, privacy, and international PR teams Identify trends and opportunities to amplify our community products and community storytelling around cultural moments Build relationships with media, press, influencers, and other external stakeholders Work closely with external PR agency Work autonomously and as part of a cross-functional team in a fast-paced environmentSkillsMarketing Communicationsexternal communicationsmedia relationsQualificationsYears of experience: 3 yearsExperience level: ExperiencedRandstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • new york, new york (remote)
    • temporary
    • $25 - $28 per hour
    A startup Fintech company is seeking Underwriting Specialists to join their growing team. We are seeking someone who has a Bachelor's in Finance, Accounting or Business Management who is open to a 3 to 6 month contract opportunity. This position is fully remote and you will be provided equipment. Having an analytical background is a must to perform the duties of this role.salary: $25 - $28 per hourshift: Firstwork hours: 9 AM - 6 PMeducation: BachelorResponsibilities Review applications for approval and determine pricing Guide renters, landlords, and real estate agents through our application process Drive revenue by working with leasing offices and brokers to close deals Improve customer retention by facilitating the renewal of existing policies Gather data on our underwriting process to fuel our never ending quest to improve our product offerings The essential functions of this role include:working weekendsSkillsUnderwritingAnalytical ThinkingMortgage UnderwritingBanking OperationsBusiness CourseworkQualificationsYears of experience: 3 yearsExperience level: ExperiencedRandstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    A startup Fintech company is seeking Underwriting Specialists to join their growing team. We are seeking someone who has a Bachelor's in Finance, Accounting or Business Management who is open to a 3 to 6 month contract opportunity. This position is fully remote and you will be provided equipment. Having an analytical background is a must to perform the duties of this role.salary: $25 - $28 per hourshift: Firstwork hours: 9 AM - 6 PMeducation: BachelorResponsibilities Review applications for approval and determine pricing Guide renters, landlords, and real estate agents through our application process Drive revenue by working with leasing offices and brokers to close deals Improve customer retention by facilitating the renewal of existing policies Gather data on our underwriting process to fuel our never ending quest to improve our product offerings The essential functions of this role include:working weekendsSkillsUnderwritingAnalytical ThinkingMortgage UnderwritingBanking OperationsBusiness CourseworkQualificationsYears of experience: 3 yearsExperience level: ExperiencedRandstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • new york, new york (remote)
    • temp to perm
    • $35 - $41 per hour
    A national insurance organization is looking for an insurance expert with a minimum of 5 years experience in professional liability to join their team. This opportunity is fully remote and is temporary to hire. Someone with a knowledge of claims adjusting, long tail claim coverage and complex liability consultant would be a great fit in this role. If that sounds like you APPLY TODAY!salary: $35 - $41 per hourshift: Firstwork hours: 8 AM - 4 PMeducation: BachelorResponsibilities Prior Experience within complex liability consulting is a plus Managing Claims and Processing Claims with a focus in: Envirnomental Claims, Product Liabilty  General liability Claims Adjustment Multiple Occurence Professional Liability  Knowledge of Contract Review a plus Minimum of 5 years of experience in Professional Liability Insurance SkillsInsurance (1 year of experience is required)Insurance Claim ProcessingLiability Insurance (5 years of experience is required)Environmental ClaimsQualificationsYears of experience: 5 yearsExperience level: ExperiencedRandstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    A national insurance organization is looking for an insurance expert with a minimum of 5 years experience in professional liability to join their team. This opportunity is fully remote and is temporary to hire. Someone with a knowledge of claims adjusting, long tail claim coverage and complex liability consultant would be a great fit in this role. If that sounds like you APPLY TODAY!salary: $35 - $41 per hourshift: Firstwork hours: 8 AM - 4 PMeducation: BachelorResponsibilities Prior Experience within complex liability consulting is a plus Managing Claims and Processing Claims with a focus in: Envirnomental Claims, Product Liabilty  General liability Claims Adjustment Multiple Occurence Professional Liability  Knowledge of Contract Review a plus Minimum of 5 years of experience in Professional Liability Insurance SkillsInsurance (1 year of experience is required)Insurance Claim ProcessingLiability Insurance (5 years of experience is required)Environmental ClaimsQualificationsYears of experience: 5 yearsExperience level: ExperiencedRandstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • south plainfield, new jersey (remote)
    • contract
    • $75 - $85 per hour
    job summary: The Contractor, Pharmacovigilance Operations contributes to oversight of the collection, processing, assessment, monitoring and follow-up of Adverse Event (AE) and Serious Adverse Event (SAE) reports from clinical trials and post-marketing sources. This is in compliance with Good Clinical Practice (GCP), and applicable global regulations and guidance documents. The incumbent monitors that AEs and SAEs are processed with a high degree of detail and accuracy and are reported in a timely manner. He/She is also responsible for monitoring that the Safety Database configuration meets applicable regulations, is kept current with products and studies, and that the vendor provides accurate outputs from the safety database in a timely manner. The incumbent works cross-functionally with internal departments and external resources on ICSR and safety database related matters.   location: South Plainfield, New Jersey job type: Contract salary: $75 - 85 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Participates in, and contributes to, the implementation and maintenance of a robust safety reporting system compliant with current applicable global regulations. This includes closely monitoring the PV vendor and the case workflow.Performs prospective and retrospective QC of cases to ensure ICSR quality and monitors that all cases move through the workflow steps to ensure compliance with regulatory timeframes. Supports and participates in training of the PV vendor on new products, protocols, and requirements.Reviews and contributes to any PV vendor documentation. This includes but may not be limited to Client Specific Guides and Safety Management Plans.Monitors configuration changes of the safety database by the vendor ensuring they are timely and meet PTC and regulatory requirements.Assists in case migrations with the vendor into the safety database monitoring quality, timeliness and complete documentation audit trail.Participates in business continuity arrangements. Assists with the authoring and implementation of PV Operations processes.Collaborates with medical monitor(s), PV leads and Regulatory Affairs to monitor the processing, submission and tracking of expedited safety reports to appropriate domestic and international regulatory authorities.Supports maintenance and archival of manual and electronic drug safety files pertaining to ICSR management.Reviews the quality of outputs from the safety database (or provide if needed) for signal meetings, safety summaries for Investigator Brochures (IBs), Developmental / Periodic Safety Update Reports (D/ PSURs) and Annual Reports.Performs other tasks and assignments as needed and specified by management.   qualifications: BSN/RN, Bachelor's degree in Biological Sciences, Pharmacy or PharmD degree or equivalent and a minimum of 5 years of progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology or related environment, including experience within pharmacovigilance operations.Demonstrated expert knowledge of relevant Food and Drug Administration (FDA), European Union (EU) and International Conference on Harmonisation (ICH) guidelines, initiatives, and regulations governing pharmacovigilance.Extensive, hands-on working knowledge of MedDRA terminology and the processing of AEs/SAEs in the pharmaceutical industry.Extensive experience of QC and workflow monitoring to ensure quality and timeliness of case processing.Demonstrated ability to identify opportunities to improve the PV reporting process(es).Ability to influence without direct authority.Proficiency with Microsoft Office.Excellent verbal and written communication and skills.Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. Preferred: Understanding of safety database administration, configuration, data entry and extraction, specifically with Argus.Expertise in the use of Electronic Document Management System (eDMS) software.Expertise in MedDRA and WHODD with relevance to coding suspect drug and concomitant medications.  skills: Argus, SAE (Serious Adverse Event), AD (Adverse Events), ICSR (Individual Case Study Report), MedDRA Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: The Contractor, Pharmacovigilance Operations contributes to oversight of the collection, processing, assessment, monitoring and follow-up of Adverse Event (AE) and Serious Adverse Event (SAE) reports from clinical trials and post-marketing sources. This is in compliance with Good Clinical Practice (GCP), and applicable global regulations and guidance documents. The incumbent monitors that AEs and SAEs are processed with a high degree of detail and accuracy and are reported in a timely manner. He/She is also responsible for monitoring that the Safety Database configuration meets applicable regulations, is kept current with products and studies, and that the vendor provides accurate outputs from the safety database in a timely manner. The incumbent works cross-functionally with internal departments and external resources on ICSR and safety database related matters.   location: South Plainfield, New Jersey job type: Contract salary: $75 - 85 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Participates in, and contributes to, the implementation and maintenance of a robust safety reporting system compliant with current applicable global regulations. This includes closely monitoring the PV vendor and the case workflow.Performs prospective and retrospective QC of cases to ensure ICSR quality and monitors that all cases move through the workflow steps to ensure compliance with regulatory timeframes. Supports and participates in training of the PV vendor on new products, protocols, and requirements.Reviews and contributes to any PV vendor documentation. This includes but may not be limited to Client Specific Guides and Safety Management Plans.Monitors configuration changes of the safety database by the vendor ensuring they are timely and meet PTC and regulatory requirements.Assists in case migrations with the vendor into the safety database monitoring quality, timeliness and complete documentation audit trail.Participates in business continuity arrangements. Assists with the authoring and implementation of PV Operations processes.Collaborates with medical monitor(s), PV leads and Regulatory Affairs to monitor the processing, submission and tracking of expedited safety reports to appropriate domestic and international regulatory authorities.Supports maintenance and archival of manual and electronic drug safety files pertaining to ICSR management.Reviews the quality of outputs from the safety database (or provide if needed) for signal meetings, safety summaries for Investigator Brochures (IBs), Developmental / Periodic Safety Update Reports (D/ PSURs) and Annual Reports.Performs other tasks and assignments as needed and specified by management.   qualifications: BSN/RN, Bachelor's degree in Biological Sciences, Pharmacy or PharmD degree or equivalent and a minimum of 5 years of progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology or related environment, including experience within pharmacovigilance operations.Demonstrated expert knowledge of relevant Food and Drug Administration (FDA), European Union (EU) and International Conference on Harmonisation (ICH) guidelines, initiatives, and regulations governing pharmacovigilance.Extensive, hands-on working knowledge of MedDRA terminology and the processing of AEs/SAEs in the pharmaceutical industry.Extensive experience of QC and workflow monitoring to ensure quality and timeliness of case processing.Demonstrated ability to identify opportunities to improve the PV reporting process(es).Ability to influence without direct authority.Proficiency with Microsoft Office.Excellent verbal and written communication and skills.Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. Preferred: Understanding of safety database administration, configuration, data entry and extraction, specifically with Argus.Expertise in the use of Electronic Document Management System (eDMS) software.Expertise in MedDRA and WHODD with relevance to coding suspect drug and concomitant medications.  skills: Argus, SAE (Serious Adverse Event), AD (Adverse Events), ICSR (Individual Case Study Report), MedDRA Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

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