Senior Manager, Global Patient Safety Scientist

SUMMARY :

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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 :

• Perform signal evaluation for identified signals and author the safety evaluation reports and Health Hazard Reports.
• Run the preparation and review of aggregate safety documents including DSUR, PSUR, RMP, IB, responses to health authority queries, and queries from other departments.
• Prepare and deliver presentations at Signal Management Team (SMT) meetings.
• Participate in clinical study team meetings for assigned compounds.
• Own the day-to-day operations and ensure the efficient functioning of the Safety Sciences team for assigned compounds.
• 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, meet deliverables, and effectively use your time and prioritize.

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 pharmaceutical / biotech industry or health authority.

The ideal candidate must possess 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! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted.

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