Drug Safety Physician
Core
Provide medical and safety support to clinical research projects, ensuring adherence to ethical principles, GCP, and pharmacovigilance standards.
Role type
Drug Safety Physician (Pharmacovigilance)
Builds
Clinical trial safety assessments and regulatory reporting for pharmaceutical clients
Domain
Healthcare / Clinical Research / Pharmacovigilance
Deliverable
client delivery
Required skills
Medical diagnosis and treatment, Adverse Event coding (MedDRA), Safety assessment (seriousness, expectedness, relatedness), Regulatory reporting, Product safety profile analysis, Code-break activities, Product Information generation
Preferred skills
Clinical research experience, Pharmacovigilance experience
Technologies
MedDRA, IND annual reports, Annual Safety Reports, Periodic Safety Update Reports
Responsibilities
Review and assess Adverse Events and Adverse Drug Reactions; Review aggregated safety reports; Provide assessment of safety issues in clinical trials and post-marketing settings; Support training on regulatory requirements for AE/ADR reporting; Provide input to Project Specific Procedures and Product Information; Assist in code-break activities; Provide consultancy to clients on safety reporting; Guide Medical and Safety Services staff on regulatory reporting.
Seniority
Mid-level, hands-on IC