The Senior Post Marketing Study Lead ensures compliant AE data collection and reporting for post-marketing studies while driving safety management workflows in line with global regulations. You will provide technical expertise in system configuration and vendor oversight to maintain high standards of pharmacovigilance excellence.
location: Telecommute
job type: Contract
salary: $50 - 58 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
Case Processing & System Management
- Execute high-quality review, coding, and data entry of post-marketing cases in the Global Safety Database.
- Serve as the functional expert for system configuration, UAT testing, and database queries to support safety data management and post-marketing studies (IST, COOP, RWE).
- Coordinate with internal stakeholders to align case processing standards with risk management and aggregate data analysis needs.
- Oversee day-to-day ICSR activities performed by vendors, ensuring all practices are consistent and compliant with global safety regulations.
- Provide comprehensive vendor support, including QC evaluations, literature surveillance, reconciliation, and the development of study-specific training materials.
- Manage queries from Business Partners and facilitate cross-functional team guidance.
- Lead the preparation of safety-related plans and contribute to safety sections of study reports, annual safety updates, and expedited reports for global submissions.
- Represent the PV department during regulatory inspections and internal quality audits, ensuring an inspection-ready state at all times.
- Manage deviation and CAPA activities and respond to safety-related queries from Regulatory Authorities or Ethics Committees.
- Identify and implement opportunities to enhance adverse event workflows and documentation processes based on regulatory updates and internal insights.
- Collaborate with GRADS, R&D Quality, and Clinical teams to monitor performance, resolve bottlenecks, and reduce regulatory risk.
- Mentor PV Operations team members to build team capability and serve as the acting team lead in the absence of the manager.
qualifications:
Required:
- BS/BA degree in a health-related or biological science field .
- 10+ years of pharmaceutical drug safety or pharmacovigilance experience .
- Expertise in FDA/international regulations, safety database applications, and MedDRA coding .
- Strong understanding of medical terminology and quality management systems .
- Flexibility to work outside normal hours or on-call as required .
skills: Pharmacovigilance, MS-EXCEL, Drug Safety, MedDRA, Individual Case Safety Report (ICSR), Food and Drug Administration (FDA)
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.
Any consideration of a background check would be an individualized assessment based on the applicant or employee's specific record and the duties and requirements of the specific job.
