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Senior Risk Management Scientist, Global Pharmacovigilance
GE HealthCare. Provide scientific and operational support for global pharmacovigilance risk management and safety signal activities across the product lifecycle.
About the role
Key responsibilities & impact- Provide scientific and operational support for global pharmacovigilance risk management and safety signal activities across the product lifecycle.
- Support the execution of risk management strategies, safety signal detection and evaluation, and regulatory compliance.
- Contribute to the development of Risk Management Plans, safety analytics, and governance deliverables.
- Prepare materials and presentations for the Product Safety Review Board (PSRB).
- Serve as an operational leader of the Drug Safety & Risk Management (DSRM).
- Coordinate and track reporting of safety issues to Product Safety Review Board (PSRB), Quality Management Review (QMR) and PV Leadership.
Requirements
What you’ll need- Advanced clinical degree (e.g., MD, DO, NP, PA, PharmD, PhD in a health-related field) required
- Significant Experience of pharmaceutical/biotechnology PV experience, including clinical trial and post-marketing experience
- Global experience preferred
- Substantial Experience in PV / Safety
- Strong knowledge in FDA, EU, ICH guidelines, initiatives and regulations governing pharmacovigilance
- Strong knowledge in safety signal evaluation and responses to safety requests from Health Authorities
Benefits
Comp & perks- Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities.
- Our salary and benefits are everything you’d expect from an organization with global strength and scale.
- You’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pharmacovigilancerisk managementsafety signal detectionsafety analyticsRisk Management Plansregulatory compliancesafety signal evaluationclinical trial experiencepost-marketing experienceFDA guidelines
Soft Skills
operational leadershipcoordinationcommunicationpresentation skillsorganizational skills
Certifications
MDDONPPAPharmDPhD