Drug Safety Physician
Core
Provide medical and safety support to clinical research and pharmacovigilance activities, ensuring projects meet ethical principles, GCP, and regulatory standards.
Role type
Licensed physician specializing in drug safety and 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, expectedness, 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; Provide input to Product Information and Company Core Data Sheets; Guide staff on regulatory reporting of adverse events; Support code-break activities; Communicate with clients on safety issues
Seniority
Mid-level, hands-on IC