Manager, Pharmacovigilance Operations (Biotech)

TL;DR

Manager, Pharmacovigilance Operations (Biotech): Providing support for drug safety operations including vendor oversight, adverse event reporting, and global safety database management with an accent on regulatory compliance and risk management. Focus on ensuring integrity of safety reporting for clinical trials and post-marketing activities.

Location: Remote in South San Francisco, CA or hybrid (onsite 3 days a week). Candidates must be authorized to work in the U.S.

Salary: $140,000–$150,000 per year

Company

Clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease.

What you will do

• Oversee safety vendors, tracking KPIs, compliance, and open query metrics.
• Facilitate preparation and submission of periodic safety reports (DSUR, 6M LL) and other regulatory filings.
• Manage regulatory reporting requirements across all studies to ensure alignment with current regulations.
• Perform MedDRA and WHODrug coding and update safety sections in Investigator Brochures, Protocols, and ICFs.
• Support SAE reconciliation between clinical and safety databases and manage the safety mailbox.
• Develop and approve PV SOPs and Work Instructions while liaising with QA for CAPA activities.

Requirements

• Authorization to work in the U.S. is required.
• Bachelor’s degree in life sciences, healthcare, or related discipline (advanced degree like RN, BSN, PharmD preferred).
• Minimum of 5 years of pharmacovigilance experience in pharma or biotech.
• Deep knowledge of US and ex-US PV regulatory requirements (US CFR, EU GVP, ICH Guidelines).
• Proficiency in safety databases such as Oracle Argus, ARISg, MedDRA, WHODrug, or SPEED.
• Strong interpersonal communication skills and ability to manage multiple projects in a fast-paced environment.

Nice to have

• Experience with device safety reporting.
• Experience with eTMF filing.
• Experience participating in regulatory inspections.

Culture & Benefits

• Competitive compensation including annual performance bonus and equity.
• Comprehensive health insurance.
• Generous time off, including two annual company-wide holiday shutdowns.
• Collaborative work environment with a focus on life-changing products for patients.