Associate Director, Global Patient Safety Lead

3 weeks ago


Uxbridge, United Kingdom Pharmiweb Full time
Job Title: Associate Director, Global Patient Safety

Regeneron is seeking an experienced Associate Director to join our Global Patient Safety team. This role is a pivotal position within our organization, specifically in the Case Evaluation & Reporting area.

Key Responsibilities:
  • Coordinate pharmacovigilance operations to ensure efficient vendor and case processing, meeting regulatory standards.
  • Play a key role in inspection readiness, quality control of PV deliverables, and adherence to case submission timelines.
  • Lead all aspects of case processing deliverables with accuracy.
  • Contribute to tactical planning for global staff development and capacity.
  • Provide mentorship and support to team members.
  • Collaborate with auditors and health authority inspectors.
  • Ensure compliance with all regulations, guidelines, guidances, and Regeneron SOPs and Working Instructions governing pharmacovigilance.
  • Lead and support direct and indirect reports.
  • Manage workload and support staff in meeting compliance objectives, optimizing job performance/contributions, and achieving high levels of work quality.
Requirements:
  • Bachelor's degree or equivalent.
  • Proven pharmacovigilance/drug safety experience in the pharmaceutical/biotech industry, with at least 10 years of experience, including clinical and post-marketing expertise.
  • Strong understanding of FDA, EU, and ICH guidelines governing pharmacovigilance.
  • Expertise in leading and supervising teams on complex projects and a successful track record of collaboration across functional teams.
About Regeneron:

We have an inclusive and diverse culture that provides comprehensive benefits, including 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.



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