Senior Manager, Global Patient Safety - General Medicine
$150.5k - $245.5kRegeneron Pharmaceuticals, Inc.
Responsibilities
- Execute signal detection activities aligned with approved safety surveillance plans
- Evaluate identified signals and prepare safety evaluation reports
- Manage safety documentation including DSUR, PSUR, RMP, and health authority responses
- Present at Signal Management Team meetings and participate in clinical study discussions
- Support cross-functional teams including RSOC, IDMC, and process improvement initiatives
Requirements
- Master's, PhD, or PharmD degree
- 7+ years pharmaceutical or biotech risk management experience
- FDA, EU, and ICH guidelines and pharmacovigilance regulations knowledge
- Safety database proficiency for medical case review and queries
- Strong written and verbal communication of safety findings
- Self-disciplined with ability to meet deliverables and prioritize effectively
Compensation: $150,500-$245,500 annually
Vacancy posted 6 days ago
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