Senior Manager, Pharmacovigilance

Job Description

Manage end-to-end pharmacovigilance activities for clinical trials and post-approval oncology products
In partnership with Clinical Research Organizations (CROs), 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
Clinical Development & Regulatory Affairs Support
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)
Assist with preparation for regulatory inspections and audits
Cross-Functional Collaboration
Participate in internal Safety Management Teams and governance meetings
Partner with Clinical, Regulatory Affairs, Medical Affairs, Quality, and Commercial teams
Support safety training for internal stakeholders and investigators
Vendor & Compliance Oversight
Support oversight of pharmacovigilance vendors and service providers
Ensure Safety Data Exchange Agreements (SDEAs) are implemented and maintained
Assist in development and maintenance of SOPs and training materials

Qualifications

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
Oncology experience in lung and/or prostate cancer
Experience in biotech/ small pharmaceutical company or CRO environments
Experience supporting NDA/MAA submissions and commercial launch
Familiarity with REMS, RMPs, and post-marketing commitments

Skills And Attributes

Strong strategic thinking combined with a hands-on, execution-focused mindset
Proven ability to collaborate and lead in a cross-functional, matrixed organization
Excellent written and verbal communication skills, with the ability to convey complex data clearly
Highly organized, adaptable, and comfortable working in a fast-paced, evolving environment
Mission-driven, patient-focused, and committed to scientific integrity