Senior Manager, Pharmacovigilance
Core
Managing safety data and ensuring patient safety by monitoring adverse events and ensuring regulatory compliance for clinical-stage drug programs.
Role type
Senior Manager, Pharmacovigilance
Builds
Safety data management and regulatory compliance for clinical-stage oncology/rare disease programs
Domain
Biopharmaceuticals, Drug Safety, Clinical Development
Deliverable
client delivery
Required skills
Pharmacovigilance regulations (FDA, EMA, ICH), ICSR management, Safety database management, Vendor management, Regulatory submission support, Oncology or rare disease experience
Preferred skills
Experience interacting with health authorities during inspections and audits
Technologies
Veeva Safety Database, MS Office
Responsibilities
Lead and manage pharmacovigilance activities for clinical-stage programs; Oversee development and maintenance of pharmacovigilance processes; Manage ICSR lifecycle from data collection to medical review; Coordinate relationships with external vendors; Contribute to safety sections of regulatory submissions
Seniority
Senior, hands-on IC