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
• 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