Senior Scientist - Aggregate Reporting
Core
Develop, review, and maintain high-quality safety and pharmacovigilance documents to support global safety surveillance and regulatory compliance for consumer health products.
Role type
Senior individual contributor pharmacovigilance medical safety scientist
Builds
Periodic Safety Update Reports (PSURs/PBRERs/PADERs), DSURs, aggregate safety reports, signal assessment reports, and regulatory submission safety sections
Domain
Pharmaceutical/Consumer Health industry + Pharmacovigilance and Medical Safety
Required skills
Advanced degree (PharmD, PhD, MD, MPH, MS), 8-10 years in pharmacovigilance/drug safety/medical writing, synthesizing data from ICSRs and clinical studies, preparing regulatory safety reports, benefit-risk assessment, literature surveillance, quality control of safety documents
Preferred skills
Experience in matrixed environments, familiarity with global pharmacovigilance regulations
Technologies
None explicitly listed
Responsibilities
Prepare and review pharmacovigilance and risk management documents, synthesize safety information from multiple sources, collaborate with Drug Safety and Regulatory Affairs teams, ensure document compliance with global regulations and SOPs, support inspection and audit readiness
Seniority
Senior, hands-on IC