Senior Medical Director / Medical Director - Endocrinology
Core
Provide medical oversight of clinical trials and marketed products to ensure regulatory compliance and safety, serving pharmaceutical clients and research organizations.
Role type
Senior Medical Director (Pharmacovigilance & Clinical Trials)
Builds
Clinical trial safety reports, periodic safety reports (PBRER, PSUR, DSUR), labeling updates, and risk management dossiers for top 50 pharma companies and biotechs.
Domain
Life Sciences / Clinical Research / Pharmacovigilance
Deliverable
client delivery
Required skills
Medical judgment for clinical decision-making, safety data analysis, regulatory guideline interpretation (FDA, ICH, EMA, GCP), therapeutic expertise, signal detection, report writing and review
Preferred skills
Active medical licensure, biostatistics knowledge, data management familiarity, mentoring capabilities
Technologies
Medra, safety databases
Responsibilities
Monitor safety variables (AEs, lab abnormalities, patient status) in clinical studies; Review and interpret adverse events and serious adverse events; Provide medical consultation to investigators and clients; Manage signal detection and aggregate safety reports; Assist in writing and reviewing CSR, IND/NDA reports, and CTD modules; Support label updates and risk management activities.
Seniority
Senior, hands-on IC with mentorship responsibilities
