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Manager, Pharmacovigilance Operations
Job in
Waltham, Middlesex County, Massachusetts, 02254, USA
Listed on 2026-02-14
Listing for:
Stratacuity: Proven Scientific Placement
Full Time
position Listed on 2026-02-14
Job specializations:
-
Healthcare
Healthcare Management, Healthcare Administration
Job Description & How to Apply Below
Manager, Pharmacovigilance Operations (Contractor)
Location: Waltham, MA
Our client, a clinical‑stage biopharmaceutical organization is seeking a Consultant Manager, Pharmacovigilance Operations to support global safety case management, vendor oversight, and PV operational activities across clinical and commercial programs. This role partners closely with internal teams and external vendors to ensure high‑quality safety reporting and regulatory compliance.
Key Responsibilities- Oversee PV case management, safety reporting, and compliance monitoring for investigational and commercial products
- Support safety operations for assigned clinical studies, including SAE reconciliation
- Contribute to Safety Data Exchange Agreements and PV‑related partner/vendor contracts
- Develop safety‑related study documents (Safety Management Plans, reporting forms, reconciliation plans)
- Support regulatory inspections, audits, and responses to health authority safety requests
- Maintain PV system policies, SOPs, and ensure alignment with evolving global regulations
- Collaborate cross‑functionally with Medical Affairs, Commercial, and other teams on safety processes
- Bachelor’s or advanced degree in life sciences or a healthcare field
- 5–7+ years of pharmacovigilance experience
- Proficiency with safety databases (ARGUS, ARISg), EDC systems, and document management tools
- Strong knowledge of GCP, ICH, FDA/EMA regulations, MedDRA, and WHO Drug
- Experience managing PV vendors and ICSR submissions
- Highly organized, detail‑oriented, and able to manage multiple priorities
- Strong communication, problem‑solving skills, and a proactive mindset
- Experience with safety database configuration/validation is a plus
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