Associate Director, Global Patient Safety - Ophthalmology
Regeneron Pharmaceuticals, Inc., Uxbridge, Greater London
Associate Director, Global Patient Safety - Ophthalmology
Salary not available. View on company website.
Regeneron Pharmaceuticals, Inc., Uxbridge, Greater London
- Full time
- Permanent
- Onsite working
Posted today, 8 Nov | Get your application in now to be one of the first to apply.
Closing date: Closing date not specified
Job ref: e01f36e81c61480191b6d9069046f40f
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
- Resource for medical review of assigned compounds
- 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 (Terminal Degree preferred) - Offers 10+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority
- Previous safety or relevant clinical experience in the pharmaceutical industry required, typically with at least 8-10+ years of risk management or relevant clinical experience in 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 querie
- 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
- Provide a background that includes: Master's, PhD, or PharmD
- Clinical experience and/or industry experience in the TA of interest is a plus
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director to join our Global Patient Safety team. The Associate Director of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases. We will expect this to include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessments. 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/associate-director-global-patient-safety-ophthalmology-127715149