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PV Operations Manager, Drug Safety
1 month ago
Location: Cambridge MA (Hybrid)
Therapeutic Area: Rare Disease
Job Overview: The PV Operations Manager will oversee ICSR case processing, medical review, and safety database management in clinical trials, requiring project management and communication skills in a dynamic environment.
Primary Job Responsibilities:
- Oversee ICSR medical review strategies in collaboration with cross-functional teams
- Manage the safety database with PV vendor oversight
- Represent DSPV in key cross-functional team meeting
- Guide vendor interactions and streamline Safety Management Plan implementation
Primary Job Requirements:
- Experienced safety professional (RN, PharmD) with at least 7+ years in drug safety, pharmacovigilance, and clinical experience from direct patient care
- Hands-on experience with good pharmacovigilance practices and international regulatory requirements (EMA/FDA/ICH) for ICSR case processing, medical review, and regulatory submissions
- Proficient with MedDRA dictionary, strong case processing, and narrative writing skills
- Experienced in using software-based drug safety systems (e.g., ARGUS, ARISg) and proficient in MS Office
- Prior experience with gene therapy products or biologics
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PROVEN SCIENTIFIC PLACEMENT™
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