Sr. Manager of Pharmacovigilance
Core
Manage end-to-end pharmacovigilance activities for late-stage clinical development and commercial launch of small-molecule oncology products in lung and prostate cancer.
Role type
Senior Manager of Pharmacovigilance
Builds
Global safety operations, regulatory submissions, and post-marketing readiness for oncology therapeutics
Domain
Healthcare / Oncology / Pharmacovigilance
Deliverable
client delivery
Required skills
Global pharmacovigilance regulations, ICSR processing, Safety Management Plans, DSURs, periodic safety reports, Investigator Brochures, clinical study protocols, signal detection, Risk Management Plans, REMS, vendor oversight, SOP development
Preferred skills
Lung and/or prostate cancer oncology experience, biotech/small pharma/CRO environment experience, NDA/MAA submission support
Technologies
Argus, ARISg
Responsibilities
Manage end-to-end pharmacovigilance activities for clinical trials and post-approval oncology products; Oversee intake, assessment, processing, medical review, and reporting of ICSRs; Ensure timely submission of expedited and periodic safety reports to Regulatory Authorities; Support preparation and submission of DSURs, periodic safety reports, and updates to Investigator Brochures; Develop, maintain, and execute Safety Management Plans for clinical studies; Contribute to safety sections of clinical study protocols, informed consent forms, and clinical study reports; Participate in periodic safety reviews, signal detection, and risk evaluation activities; Support launch readiness activities including development of post-marketing pharmacovigilance processes and Risk Management Plans; Assist with preparation for regulatory inspections and audits; Partner with Clinical, Regulatory Affairs, Medical Affairs, Quality, and Commercial teams; Support oversight of pharmacovigilance vendors and service providers
Seniority
Senior Manager, hands-on operational leadership
