Global Patient Safety Scientist
2 days ago
Job Summary
The Associate Director, Global Patient Safety Scientist will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases, under the guidance of the safety lead.
This will include review, analysis and interpretation of safety data (including aggregate data) to generate appropriate safety messaging and benefit-risk assessments.
Key Responsibilities
- Complete signal detection activities in line with approved safety surveillance plan.
- Perform signal evaluation for any identified signals and author the safety evaluation reports.
- Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queries.
- Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds.
- Participate in other risk management activities as appropriate for assigned compounds.
Requirements
- Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments.
- Ability to work with a safety system database.
- Ability to prioritize and multitask to meet deliverables.
- Ability to effectively communicate (verbal and written) safety findings.
Education and Experience
- Master's, PhD, or PharmD (preferred).
- 10+ years of relevant safety related experience in the pharmaceutical/biotech industry or health authority.
Regeneron Pharmaceuticals is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
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Tarrytown, New York, United States Regeneron Pharmaceuticals Full timeJob SummaryWe are seeking a highly skilled Associate Director, Global Patient Safety Scientist to join our team at Regeneron Pharmaceuticals. As a key member of our Global Patient Safety team, you will play a critical role in ensuring the safety of our products and contributing to the development of our safety strategies.Key ResponsibilitiesReview, analyze,...
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Tarrytown, New York, United States Regeneron Pharmaceuticals Full timeJob SummaryWe are seeking an experienced Associate Director, Global Patient Safety Scientist to join our team at Regeneron Pharmaceuticals. This role will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases.Key ResponsibilitiesReview, analyze, and interpret safety data to generate appropriate safety...
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