Senior Manager, Global Patient Safety - General Medicine
Regeneron Pharmaceuticals, Inc., Uxbridge, Greater London
Senior Manager, Global Patient Safety - General Medicine
Salary not available. View on company website.
Regeneron Pharmaceuticals, Inc., Uxbridge, Greater London
- Full time
- Permanent
- Onsite working
Posted 1 week ago, 23 Sep | Get your application in now before you're too late!
Closing date: Closing date not specified
Job ref: bb54fdcf6faf4cd1939d1cccafd1c959
Location ref: Uxbridge, Greater London
Full Job Description
- 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
- We may ask you to 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 e.g. the development and maintenance of relevant SOPs, WIs and supporting documents
Minimum a Master's, PhD, or PharmD - Offers 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, you can meet deliverables, and effectively use your time and prioritize
- Ability to effectively communicate (verbal and written) safety findings
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager to join our Patient Safety team. 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. We will expect this to include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Direct job link
https://www.jobs24.co.uk/job/senior-manager-global-patient-safety-general-medicine-127447741