Senior Manager, Pharmacovigilance
Job Description:
- Manage end-to-end pharmacovigilance activities for clinical trials and post-approval oncology products
- Oversee intake, assessment, processing, medical review, and reporting of ICSRs from clinical trials, adhering to established processes and timelines
- Ensure timely submission of expedited and periodic safety reports to Regulatory Authorities, IRBs/ECs, clinical investigators, and business partners
- Support preparation and submission of DSURs, periodic safety reports/listings, and updates to Investigator Brochures (IBs)
- Develop, maintain and execute Safety Management Plans for clinical studies
- Contribute to safety sections of clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and IND/NDA/MAA/CTAs (as applicable)
- Review clinical trial safety data and assist with data cleaning for ongoing studies
- Participate in periodic safety reviews, signal detection and risk evaluation activities
- Maintain Reference Safety Information for ORIC products and co-administered IMPs
- Support launch readiness activities including development of post-marketing pharmacovigilance processes, development and maintenance of Risk Management Plans (RMPs) and REMS (as applicable)
Requirements:
- Bachelor’s degree in life sciences, pharmacy, nursing, or related discipline with demonstrated knowledge of medical terminology
- 12 years’ pharmacovigilance experience with Bachelor's degree -or- 8 years’ experience and Master's degree -or- 5 years’ experience and PhD-including clinical trial and/or post-marketing experience
- Experience with small-molecule oncology products
- Working knowledge of global pharmacovigilance regulations, including FDA, EMA, Health Canada, and Asian Health Authorities (e.g., Japan PMDA, South Korea MFDS)
- Experience using validated safety databases (e.g., Argus, ARISg) and clinical trial databases
Benefits:
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development opportunities