Senior Manager, Pharmacovigilance

🌍 Remote, USA 🚀 Full-time 🕐 Posted Recently

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)

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