Global Medical Safety Leader

2 weeks ago


Lexington, Kentucky, United States Kiniksa Pharmaceuticals Full time
Job Summary

We are seeking a highly experienced and strategic leader to join our team as Vice President, Global Medical Safety. This role will be responsible for providing medical oversight for the global drug safety and pharmacovigilance function, ensuring proactive and timely benefit-risk assessments of all safety data.

Key Responsibilities
  • Lead global clinical, medical, and scientific safety, pharmacovigilance, and risk management activities throughout the product lifecycle for investigational and marketed products across the pipeline.
  • Develop and implement strategies to ensure compliance with regulatory requirements and industry standards.
  • Collaborate with cross-functional teams to ensure effective communication and response to product safety queries from all sources.
  • Build and manage a high-growth global medical safety team by setting clear expectations and providing hands-on leadership.
  • Provide strategic consultation, guidance, and oversight for safety sections of all regulatory documents.
Requirements
  • MD, or MD PhD, or MD MPH required. U.S. Licensure and Board Certification are preferred.
  • A minimum of 15+ years' experience as the Head of Drug Safety/Patient Safety/Product Safety & Pharmacovigilance for a bio-pharmaceutical/pharmaceutical company.
  • Direct knowledge and experience of major filings such as IND, CTA, NDA, and MAAs.
  • Entrepreneurial, small/high-growth company biologics experience is preferred or rare disease experience is a plus.
About Kiniksa Pharmaceuticals

Kiniksa Pharmaceuticals is an Equal Opportunity employer and is committed to diversity and inclusion in the workplace. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.



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