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About the Role
The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the assigned Therapeutic Area. This includes safety data aggregation, review, and analysis to support appropriate safety interpretation and benefit-risk assessment.
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
- Represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC) and other teams with members external to Regeneron
- Actively participate in process improvement initiatives, including the development and maintenance of relevant SOPs, WIs and supporting documents
Requirements
- Minimum a Master's, PhD, or PharmD
- 7+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority
- 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 for purposes of medical case review and simple queries
- Able to be proactive and self-disciplined, meet deliverables, and effectively use time and prioritize
- Ability to effectively communicate (verbal and written) safety findings
Location
- Uxbridge, UK
Work Type
- 3 days per week on site
Experience Level
- Senior Manager
Education Level
- Master's
- PhD
- PharmD
Benefits
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits (e.g. medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
About the Company
- Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
- This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Equal Opportunity
- Regeneron 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
- Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.