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Medical Director, Global Pharmacovigilance
GE HealthCareMedical Director role at GE HealthCare focusing on drug safety and pharmacovigilance. Involvement in regulatory compliance and individual case safety reports for pharmaceutical products.
About the role
Key responsibilities & impact- Serves as Medical Reviewer for Individual Case Safety Reports (ICSRs).
- Gathers, reviews, and evaluates scientific and clinical data.
- Prepares and contributes medical safety content for regulatory documents.
- Supports safety signal detection and evaluation activities.
- Authors high-quality safety review documents and evaluations.
Requirements
What you’ll need- Experience in drug safety risk management and pharmacovigilance.
- Relevant experience in clinical development or medical affairs.
- Minimum of 5 years of pharmaceutical/biotechnology PV experience.
- Strong knowledge in FDA, EU, ICH guidelines.
- Proven ability to utilize MedDRA and WHO DD dictionary coding.
Benefits
Comp & perks- Total rewards designed to unlock your ambition.
- Flexible working arrangements.
- Career opportunities in a supportive culture.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
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Hard Skills & Tools
drug safety risk managementpharmacovigilanceclinical developmentmedical affairsMedDRA codingWHO DD dictionary coding
Soft Skills
evaluationdata analysiscommunication