Drug Safety Specialist
Core
Provide drug safety reporting and management services for clinical trials, ensuring compliance with protocols and regulations.
Role type
Drug Safety Specialist (Pharmacovigilance)
Builds
Safety reports, narratives, and Safety Reporting Plans (SRPs) for pharmaceutical/biotech clients
Domain
Pharmaceutical / Biotechnology / Clinical Research
Deliverable
client delivery
Required skills
Safety event assessment and tracking, case narrative generation, SRP creation and review, regulatory compliance oversight, literature review, MedDRA and WHO Drug coding knowledge
Preferred skills
DSUR experience, safety/pharmacovigilance database experience
Technologies
MS Word, Excel
Responsibilities
Receive, assess, process, and track safety-related events (SAEs, EIU reports); Generate accurate case narratives; Create and review study-specific Safety Reporting Plans; Participate in study kick-off meetings; Act as Lead Safety Officer for regulatory compliance
Seniority
Mid-level, hands-on IC