Associate Director Pharmacovigilance

3 weeks ago


New Bedford, Massachusetts, United States Lantheus Full time

Job Summary

Lantheus is seeking an experienced Associate Director Pharmacovigilance to join our Global Pharmacovigilance team. This role will focus on managing business partnerships and coordinating pharmacovigilance activities for developmental products.

The ideal candidate will have a strong understanding of US and ex-US pharmacovigilance regulatory requirements and experience with ICH E2B-compliant databases. They will also have excellent communication and project management skills, with the ability to work independently and lead projects.

Key Responsibilities

  • Lead interactions with Lantheus' Clinical Research team and pharmacovigilance vendors to ensure safety reports are processed consistently and compliantly.
  • Provide technical support for safety database management and ensure information is accurate and complete.
  • Develop and maintain pharmacovigilance plans, including safety management plans and standard operating procedures.
  • Oversee deviation and CAPA activities related to pharmacovigilance.
  • Collaborate with Regulatory Affairs and Quality Assurance functions to maintain current knowledge of regulatory safety reporting guidelines.

Requirements

  • Bachelor's or advanced degree in a life science or related field.
  • 8+ years of direct pharmacovigilance experience in the pharmaceutical industry.
  • Experience with ICH E2B-compliant databases and pharmacovigilance regulatory requirements.
  • Excellent communication and project management skills.

What We Offer

Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants. We offer a dynamic and inclusive work environment, with opportunities for professional growth and development.



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