Senior Risk Management Scientist, Global Pharmacovigilance
GE HealthCare
full-time
Posted on:
Location Type: Remote
Location: United States
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Job Level
About the role
- 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
- 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
- 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.
Applicant 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