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, signal management deliverables, and risk assessment documentation for life sciences clients.
Domain
Life Sciences / Pharmacovigilance / Drug Safety
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Signal detection and validation, aggregate report authoring (PBRER/PSUR/DSUR/ACO), literature safety surveillance, regulatory inquiry response, molecule-level ownership, cross-functional stakeholder liaison, audit participation, SOP compliance.
Preferred skills
Drug safety hands-on experience, knowledge of specific molecules and disease areas, signal management strategy setup.
Technologies
None explicitly stated
Responsibilities
Conduct ongoing signal detection and literature surveillance; Author and finalize aggregate safety reports; Respond to regulatory agency and PRAC inquiries; Lead molecule-level signal management and validation; Coordinate molecule work distribution and oversight; Participate in internal and external audits and inspections.
Seniority
Mid-Senior, hands-on IC
