Manager, Global Patient Safety Scientist

Regeneron Pharmaceuticals, Inc.; Uxbridge; On-site; GBP 70,000 - 110,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Manager to join the Global Patient Safety Sciences team in the UK. You will lead signal detection/evaluation activities and contribute to safety documentation across clinical development and post-marketing environments.

Role includes presenting at SMT meetings, collaborating with RSOC/IDMC and cross-functional teams to ensure rigorous safety interpretation and benefit-risk assessment.

Qualifications

• Minimum Master degree, PharmD or PhD.
• 5+ years of risk management or relevant clinical experience in pharma/biotech or health authority.
• Experience applying FDA, EU and ICH guidelines governing pharmacovigilance.

Responsibilities

• Complete signal detection activities in line with the safety surveillance plan.
• Perform signal evaluation and author safety evaluation reports.
• Manage preparation/review of DSUR, PSUR, RMP, and regulatory responses.
• Prepare and present at Signal Management Team (SMT) meetings; support clinical study teams.

Skills

Pharmacovigilance

FDA/EU/ICH guidelines

Data analysis

Cross-functional collaboration

Project management

Safety surveillance

Communication

Education

Master's Degree

PharmD

PhD

Tools

Excel

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
• Experience in data manipulation and visualization (Excel, PIVOT tables, etc) for safety analysis
• Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents
  Minimum Master degree, PharmD, PhD
• Previous safety or relevant clinical experience in the pharmaceutical industy required, typically with at least 5+ years of risk management or relevant clinical experience in pharmaceutical/ biotech industry or health authority
• Clinical experience and/or Industry experience in the TA of interest is a plus
• 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
• Demonstrates advanced understanding of safety surveillance activities and principles; continues to operate under supervision by more senior members of the GPS safety sciences team
• 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 Manager to join our Global Patient Safety Sciences team.
• The Manager 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 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.