Pharmacovigilance Scientist 2 (Safety Aggregate Report Specialist 2)
Core
Lead signal detection, literature surveillance, and authoring aggregate safety reports (PBRERs/PSURs, DSURs, ACOs) for marketed and investigational pharmaceutical products.
Role type
Senior Pharmacovigilance Scientist (Safety Aggregate Report Specialist)
Builds
Regulatory safety reports and signal management deliverables for pharmaceutical molecules
Domain
Life Sciences / Pharmacovigilance / Drug Safety
Required skills
Signal detection, aggregate report authoring, literature safety surveillance, signal validation, regulatory inquiry response, cross-functional liaison, quality oversight, audit participation, SOP adherence
Preferred skills
Molecule ownership, signaling strategy setup, proactive risk characterization, lessons learned facilitation
Technologies
PBRER, PSUR, DSUR, ACO, PRAC
Responsibilities
Conduct ongoing literature safety surveillance and signal detection; Author and finalize aggregate safety reports; Respond to regulatory agency inquiries; Serve as principal owner for specific molecules; Coordinate molecule work distribution within the team; Ensure consistent tracking of signals from detection to assessment; Participate in internal and external audits and inspections; Adhere to IQVIA and customer SOPs.
Seniority
Senior, hands-on IC