Global Safety Strategist for Ophthalmology
hace 5 días
Job Summary
We are seeking a Senior Manager of Global Patient Safety who will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the Ophthalmology Therapeutic Area.
This includes safety data aggregation, review, and analysis to support appropriate safety interpretation and benefit-risk assessment.
The ideal candidate will have the ability to apply relevant FDA, EU, and ICH guidelines, initiatives, and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments.
A typical day for this role might include performing signal evaluation, authoring safety evaluation reports and Health Hazard Reports, running aggregate safety document preparation and review, preparing presentations for Signal Management Team meetings, participating in clinical study team meetings, and owning day-to-day operations for the Safety Sciences team.
Key Responsibilities:
- Signal evaluation and safety reporting
- Aggregate safety document preparation and review
- Presentation preparation and delivery
- Clinical study team participation
- Safety Sciences team leadership
Requirements:
- Relevant experience in safety or clinical development
- FDA, EU, and ICH guidelines knowledge
- Excellent organizational and relationship leadership skills
- Strong technical and problem-solving skills
- Ability to build collaborative partnerships internally and externally
- Self-discipline and time management skills
Salary Range: $140,000 - $170,000 per year
About Regeneron
Regeneron is an equal opportunity employer and offers a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.
Location: (To be determined)
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