GRA/Drug Safety (GRADS) Alliance Management Specialist
1 Year Contract
MUST HAVE
- B S Degree (Life Science, Health Care, Nursing, Pharmacy)
- 5 years of pharma or biopharma industry experience
- Background in PV Operations and PV licensing activities ( assessing, writing, negotiating & maintaining pharmacovigilance exhibits for indirect to GRADS vendor partners)
- Proficient in QMS processes including: Deviations, Audits & Inspection Observations, CAPA, Change Control Management
location: Telecommute
job type: Contract
salary: $50.00 - 56.67 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Organizes and conducts meetings with internal Company stakeholders such as commercial for the negotiation, implementation, and maintenance activities for pharmacovigilance exhibits for indirect to GRADS vendor partners with oversight from team leader as needed.
- Assesses, writes, updates, maintains, and stores pharmacovigilance agreements and pharmacovigilance exhibits according to internal checklists and guidelines as well as company policies and standards with oversight from team leader as needed.
- Collaborates with GRADS PVAM team leader to ensure training needs are assessed for each executed agreement; liaises with the appropriate GRADS business SMEs to orchestrate the appropriate training is created by the business, as applicable, regarding new processes for each business agreement.
- Collaborates with GRADS Compliance as well as Quality to participate in audits and inspections as the SME for a PVA or PVE with a partner during any audit or inspection. With assistance from team leader, exercises decision rights in the scope of each agreement as it pertains to the audit or inspection.
- Collaborate with GRADS Compliance organization to resolve any compliance or quality issues in PV resulting from executed partnerships.
- Serves as a resource for others in the company in interpreting, developing, and applying pharmacovigilance compliance requirements in the licensing strategy.
- Works with peers to anticipate roadblocks to agreement execution and to develop a path towards the resolution of complex business problems to ensure GRADS functional areas are contributing in the most efficient but compliant manner.
- With assistance from leadership as needed, presents complex processes, anticipates potential objections, and persuades others to adopt a different point of view if appropriate.
- Anticipates internal/external business and regulatory compliance issues and works with SMEs to recommends process improvements/solutions in conjunction with the GRADS Compliance organization.
- With oversight from the team leader, orchestrates the creation and maintenance assigned business partner rules/algorithms in the safety database with IS and/or PV Operations.
- Responsible for raising deviations as needed to ensure efficiency and overall quality of activities as it relates to PV Licensing/Alliance Management.
- Organizes and conducts meetings with Company business development partners to represent Company and negotiate pharmacovigilance agreements with oversight from team leader.
- Organizes and conducts meetings with internal GRADS stakeholders for the implementation and maintenance activities in pharmacovigilance agreements with oversight from team leader.
- Responsible for orchestrating the transfer of legacy data with IS and/or PV Operations to or from the business partner and ensures it is both appropriate and complete as per terms in the agreement with oversight from team leader.
- Contribute to determining solutions outside of current responsibilities as needed and manages day-to-day operational issues outside of current responsibilities as needed.
qualifications:
- Bachelor of Science Degree in Life Sciences or Health Care (Engineering, Public Health, Biology, Chemistry, Nursing, Pharmacy) or related discipline.
- At least 5 years of biopharmaceutical experience with at least 1 years in pharmacovigilance.
- At least 1 years in pharmacovigilance licensing activities or related activities.
- Formidable negotiations skills.
- Must have proven track record to be able to think critically, strategically, independently and problem solve.
- Proficiency in Quality Management System activities such as, but not limited to, deviation, audit, and inspection observation, CAPA and change control management.
- Must have high level of motivation, drive, and demonstration of Company leadership values.
- Excellent written and verbal communication skills and negotiation skills including ability to write clearly and concisely.
- Top notch interpersonal skills in difficult situations.
- Driver of change and innovation.
- Ability to work seamlessly with all levels of personnel.
- Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations.
- Excellent Microsoft office application skills as well as, e-mail and online meeting tool skills.
skills: Pharmacovigilance, Drug Safety, Good Pharmacovigilance Practices (GVP), Safety Data Exchange Agreements (SDEAs), PV CAPA Management, Quality Management Systems (QMS)
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.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
