Sr Drug Safety Scientist
Core
Operational lead responsible for receiving, assessing, processing, and reporting global adverse drug events for pharmaceutical, nutrition, and biological products.
Role type
Senior Drug Safety Scientist (Operational Lead)
Builds
Global safety data exchange, Periodic Adverse Drug Experience Reports (PADER), individual case safety reports, and REMS program compliance.
Domain
Pharmaceutical industry / Pharmacovigilance
Deliverable
client delivery
Required skills
Adverse drug event reporting, FDA reporting compliance, PADER preparation, SDEA management, REMS operations, signal detection, regulatory interpretation, data synthesis, peer review, training development
Preferred skills
Clinical/hospital experience, post-marketing pharmaceutical industry experience, LifeSphere MultiVigilance experience
Technologies
Aris global systems, MedDRA, WHO drug coding, Microsoft Office Suite
Responsibilities
Process global adverse drug events in accordance with SOPs and FDA regulations; conduct peer review in KabiSafe LSMV and gCMW; liaise with Global Vigilance Medical Manager for medical assessment; serve as SME for ADE processing and FDA reporting; lead planning and maintenance of training materials; oversee preparation of PADER and individual case safety reports; maintain knowledge of regulations and product data; lead development of Safety Data Exchange Agreements (SDEAs); implement and monitor REMS programs; collaborate on compliance issue resolution; assist in creating department procedures.
Seniority
Senior, hands-on IC with leadership focus
