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location: Clark, New Jersey
job type: Contract
work hours: 9 to 5
education: Bachelors
responsibilities:
- Prioritization of workload for US OTC/Medical Devices (MD) & Hospital visit cases, data entry, MedDRA coding and completion of case narratives of incoming potential Health Related Complaints (HRCs) into the Post-marketing Safety (PMS) database while ensuring completeness and legibility.
- Reconciliation of daily cases received from Consumer Care Center (CCC), identify missing cases, correct errors in the Salesforce database & notify CCC manager of discrepancies.
- Provide feedback using discretion regarding database issues or with case details that are documented by CCC and communicate database discrepancies.
- Support PMS team members with projects regarding completion of cases with missing data or formula numbers as needed and serve as a backup for preparing statistical reports.
- Perform data extractions for global PMS analyses and validate data.
- Provide ongoing training/feedback of operating tools coordinating with colleagues in France to ensure accuracy.
- Provide prompt queries of vendor's database to review all AEs received, notify appropriate partner contacts, review for potential quality-related complaints, notification of manufacturing sites, while maintaining appropriate recording and archiving of information.
- Conduct database and data entry training of PMS newcomers within the Americas zone.
- Ensure documentation management of departmental work files, including organization of department training documents, Quality Investigations, and maintenance of FDA correspondence.
- Review/update standard operating procedures (SOP) and work processes (WP) as needed.
- Participate in department presentations to CCC or other métiers.
- Ensures compliance with company policies, procedures, and standards.
- Ensuring prioritization of data entry workload (OTC/Hospital/MD cases), data exploitation/validation working with colleagues in Global Data Management, ensure department document retention, while working with other Sr. Scientists, Vigilance Coordinators & Head of Post-Marketing Safety.
qualifications:
Required:
- A completed BS or MS in biology or a related field preferred with case processing experience & relevant data exploitation experience in pharmacovigilance.
- Minimum of 3-5 years of relevant experience.
- Experience in MedDRA coding preferred.
- Basic understanding of US Regulations pertaining to Post Marketing Safety preferred.
- Knowledge of medical terminology preferred.
- Excellent communication (verbal, written) and interpersonal skills required.
- Well organized while handling multiple projects simultaneously.
- Demonstrated skills in analyzing, reporting, and documenting information with strong attention to detail.
- Ability to work independently with minimum supervision in a matrix environment.
skills: Cell Biology, Biology, Microbiology
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.
