Senior Manager, Global Patient Safety Expert

vor 4 Wochen

Frankfurt am Main, Hessen, Deutschland Pharmiweb Vollzeit
Job Summary

We are seeking a Senior Manager of Global Patient Safety to 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.

Key Responsibilities
  • Perform signal evaluation for identified signals and author 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
  • Owning the day-to-day operations and directly contributing to the efficient functioning of the Safety Sciences team for assigned compounds
  • Actively participating in process improvement initiatives, such as the development and maintenance of relevant SOPs, WIs, and supporting documents
Requirements
  • Ability to apply relevant FDA, EU, and ICH guidelines, initiatives, and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments
  • Demonstrated 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 using your time and prioritizing
Qualifications
  • Previous safety or relevant clinical experience in the pharmaceutical industry required, 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

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.

The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

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