Manager, Drug Safety Physician
Core
Conduct medical reviews of individual case safety reports (ICSRs), screen scientific literature for safety signals, and prepare periodic safety reports.
Role type
Manager, Drug Safety Physician
Builds
Safety databases, periodic safety reports (PSURs, PBRERs, RMPs), and signal detection processes
Domain
Life Sciences / Pharmacovigilance
Deliverable
client delivery
Required skills
Medical review of ICSR, MedDRA coding, causality assessment, scientific literature screening, PSUR/PBRER/RMP preparation, signal detection, ICH/EMA guideline implementation, mentorship of PV associates
Preferred skills
PG degree, corporate/pharma/life sciences industry experience
Technologies
Internal search mechanisms, external tools and providers, patient safety databases
Responsibilities
Conduct medical review and assessment of ICSR into the safety database; Review and verify appropriate selection of adverse events from source documents; Screening of scientific literature; Train and mentor PV associates; Escalate complex case issues; Review and preparation of periodic safety reports; Collaborate with Global Pharmacovigilance team for Signal Detection
Seniority
Manager, hands-on IC with team leadership