Senior Manager, Pharmacovigilance

Job reputed company:

• Manage end-to-end pharmacovigilance activities for clinical trials and post-approval oncology products
• reputed company intake, assessment, processing, medical review, and reporting of ICSRs from clinical trials, adhering to established processes and timelines
• Ensure reputed company submission of expedited and periodic safety reports to Regulatory Authorities, IRBs/reputed company, clinical investigators, and business partners
• Support preparation and submission of DSURs, periodic safety reports/listings, and updates to Investigator Brochures (IBs)
• reputed company, 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 reputed company 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
• reputed company time off
• reputed company development opportunities

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