Safety Aggreg Report Mng /Senior PV Scientist
Core
Lead global functional roles for Safety Aggregate Reports and Analytics (SARA) deliverables, including aggregate reporting, literature surveillance, and signal management for marketed and investigational products.
Role type
Senior Pharmacovigilance Scientist (Safety Aggregate Reporting & Signal Management)
Builds
Regulatory safety reports (PBRERs/PSURs, DSURs, RMPs), signal detection strategies, and literature surveillance deliverables.
Domain
Life Sciences / Pharmacovigilance
Required skills
Aggregate report authoring, signal detection and validation, literature surveillance, regulatory agency response management, team leadership, data mining methodologies
Preferred skills
Drug safety experience, complex project management, audit readiness, process improvement
Technologies
Internal and external safety data sources, data mining algorithms
Responsibilities
Lead and author aggregate safety reports (PBRERs, PSURs, DSURs, RMPs), manage signal detection and validation activities, conduct literature safety surveillance, oversee safety management teams, prepare for regulatory audits, mentor project staff, and provide consultative guidance to stakeholders.
Seniority
Senior, hands-on IC with leadership responsibilities
