Associate Director, Global Patient Safety - Ophthalmology

Regeneron Pharmaceuticals, Inc.; Uxbridge; In loco; GBP 120.000 - 180.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Comprehensive benefits package

Descrizione del lavoro

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director for Global Patient Safety to lead safety strategies for molecules in development and post-marketing.

You will oversee data aggregation, review and analysis to support safety interpretations and benefit-risk assessments. The role requires extensive pharmaceutical safety experience and the ability to work cross-functionally with external members such as RSOC and IDMC, contributing to a fast-growing, science-driven organization

Competenze

• Excellent verbal and written communication skills.
• Ability to apply FDA/EU/ICH pharmacovigilance guidelines.

Mansioni

• Complete signal detection activities in line with approved safety surveillance plan.
• Perform signal evaluation and author safety evaluation reports.
• Prepare and review safety documents (DSUR, PSUR, RMP, responses).
• Deliver presentations at SMT meetings and participate in CTS meetings for assigned compounds.
• Represent GPS on cross-functional teams (RSOC, IDMC) when needed.
• Provide medical review of assigned compounds and support process improvements.

Conoscenze

Communication

Risk management

Safety review

Formazione

Master's/PhD/PharmD

Descrizione del lavoro

• 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.