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Medical Director, Global Pharmacovigilance
GE HealthCare. Serves as Medical Reviewer for Individual Case Safety Reports (ICSRs).
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