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, periodic safety reports, and product safety profiles
Domain
Healthcare / Clinical Research / Pharmacovigilance
Deliverable
client delivery
Required skills
Medical diagnosis and treatment, Adverse Event coding (MedDRA), Safety assessment (seriousness, relatedness), Regulatory reporting, Clinical trial oversight
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 input to Product Information and Core Data Sheets; Guide staff on regulatory reporting; Communicate with clients on safety issues
Seniority
Mid-level, hands-on IC