Senior Manager, Pharmacovigilance

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee the complete pharmacovigilance processes for clinical trials and post-approval oncology products.

• Manage the intake, evaluation, processing, medical assessment, and reporting of Individual Case Safety Reports (ICSRs) from clinical trials, ensuring compliance with defined procedures and timelines.

• Guarantee the prompt submission of expedited and routine safety reports to Regulatory Authorities, Institutional Review Boards/Ethics Committees (IRBs/ECs), clinical investigators, and business partners.

• Assist in the preparation and submission of Development Safety Update Reports (DSURs), periodic safety reports/listings, and updates to Investigator Brochures (IBs).

• Create, uphold, and implement Safety Management Plans for clinical studies.

• Contribute to the safety components of clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs), and investigational new drug/new drug application/marketing authorization application/clinical trial applications (IND/NDA/MAA/CTAs) where applicable.

• Review safety data from clinical trials and aid in data cleaning for ongoing studies.

• Engage in periodic safety evaluations, signal detection, and risk assessment activities.

• Maintain Reference Safety Information for ORIC products and co-administered Investigational Medicinal Products (IMPs).

• Support activities related to launch readiness, including the development of post-marketing pharmacovigilance procedures and the creation and maintenance of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS) as applicable.

• Assist in preparation for regulatory inspections and audits.

• Participate in internal Safety Management Teams and governance meetings.

• Collaborate with Clinical, Regulatory Affairs, Medical Affairs, Quality, and Commercial teams.

• Facilitate safety training for internal stakeholders and investigators.

• Ensure the implementation and maintenance of Safety Data Exchange Agreements (SDEAs).

⛳️ Requirements

• Bachelor’s degree in life sciences, pharmacy, nursing, or a related field with proven knowledge of medical terminology.

• 12 years of pharmacovigilance experience with a Bachelor's degree -or- 8 years of experience and a Master's degree -or- 5 years of experience and a PhD, including experience in clinical trials and/or post-marketing.

• Familiarity with small-molecule oncology products.

• Proficient understanding of global pharmacovigilance regulations, including those from the FDA, EMA, Health Canada, and Asian Health Authorities (e.g., Japan PMDA, South Korea MFDS).

• Experience with validated safety databases (e.g., Argus, ARISg) and clinical trial databases.

🏝️ Benefits

• Health insurance.

• Retirement plans.

• Flexible work arrangements.

• Paid time off.

• Professional development opportunities.