Senior Manager, Global Patient Safety Scientist

SUMMARY

We are seeking a Senior Manager of Global Patient Safety who will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the Ophthalmology Therapeutic Area. This includes safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment.

As a Senior Manager of Global Patient Safety, a typical day might include the following:

1. Perform signal evaluation for identified signals and author the safety evaluation reports and Health Hazard Reports.
2. Run the preparation and review of aggregate safety documents including DSUR, PSUR, RMP, IB, responses to health authority queries and queries from other departments.
3. Prepare and deliver presentations at Signal Management Team (SMT) meetings.
4. Participate in clinical study team meetings for assigned compounds.
5. Own the day-to-day operations and direct the efficient functioning of the Safety Sciences team for assigned compounds.
6. Actively participate in process improvement initiatives e.g., the development and maintenance of relevant SOPs, WIs and supporting documents.

This role might be for you if:

• You have the ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments.
• You demonstrate the ability to contribute positively to a healthy, diverse and inclusive team environment.
• Excellent organizational and relationship leadership skills.
• Strong technical and problem-solving skills/experience.
• Ability to build and strengthen collaborative partnerships internally and externally.
• Proactive and self-disciplined, meeting deliverables, and effectively managing your time and priorities.

To be considered for this opportunity, you must have:

• Previous safety or relevant clinical experience in the pharmaceutical industry, typically with at least 8 years of industry or relevant clinical experience in the pharmaceutical/biotech industry or health authority.
• A Master’s, PhD, or PharmD.

We need someone who will represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee (RSOC) and other teams with members external to Regeneron.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way!

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