Senior Manager, PVRM Safety Scientist
Core
Lead Pharmacovigilance and Risk Management (PVRM) activities, serving as the primary safety point of contact for assigned oncology and neurology programs to ensure safety governance and benefit-risk evaluation.
Role type
Senior Manager, Pharmacovigilance Scientist (IC)
Builds
Safety evaluation and risk management activities for investigational and marketed products
Domain
Pharmaceutical industry, Oncology, Neurology, Pharmacovigilance
Required skills
Pharmacovigilance, Drug safety, Benefit-risk assessment, Signal detection, Aggregate safety reporting, Regulatory submissions (FDA/EMA), Clinical data interpretation, Cross-functional leadership
Preferred skills
Oncology/Neurology experience, Leading cross-functional programs, Advanced degree
Technologies
GCP, GVP, ICH guidelines
Responsibilities
Lead cross-functional Safety Management Team (SMT) meetings; Contribute to signal detection and evaluation; Maintain ongoing monitoring of safety profiles; Review adverse event reports and clinical coding; Facilitate escalation of safety issues; Support preparation of regulatory submissions (ISS, SCS, RMPs, REMS); Develop SOPs and safety documents; Coordinate responses to regulatory authorities.
Seniority
Senior Manager, hands-on IC with leadership responsibilities