Manager, Pharmacovigilance Operations
$140,000–$150,000 year
RemoteSouth San Francisco, California, United States
Job Summary
Track safety vendor KPIs, compliance metrics, and open queries while managing eTMF filings for Allogene studies. Facilitate periodic safety report submissions, including DSURs and 6M LLs, and assist with MedDRA and WHODrug coding. Manage regulatory reporting requirements across all studies, maintain the SUSAR tracker with monthly reconciliations, and liaise with QA for CAPA activities. Support study management meetings, prepare safety sections in investigator brochures and protocols, and resolve safety mailbox communications. Participate in regulatory inspections and PV audits to ensure quality and compliance. This role reports to the Director, Pharmacovigilance and requires a Bachelor's degree in life sciences with five years of PV experience.
Required Qualifications
- Bachelor's degree in life sciences, healthcare, or a related discipline
- Minimum of 5 years of pharmacovigilance experience in a pharmaceutical or biotechnology company
- Solid understanding and working knowledge of US and ex-US pharmacovigilance regulatory requirements (e.g., US Code of Federal regulations; European Union GVP legislation; and ICH Guidelines)
- Proficiency in safety databases and other systems (e.g., Oracle Argus, ARISg, MedDRA, WHODrug, SPEED)
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
- Ability to work independently and collaboratively in a fast-paced environment and manage multiple projects simultaneously
- Strong interpersonal skills including verbal and written communication
- Candidates must be authorized to work in the U.S.
Desired Qualifications
- advanced degree (e.g., RN, BSN, PharmD)
- Experience with device safety reporting, eTMF filing, and regulatory inspections
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