Associate Director Pharmacovigilance Lead

21 hours ago

Bedford, Massachusetts, United States Lantheus Full time
Job Title: Associate Director Pharmacovigilance

Lantheus is a leading healthcare company that has been pioneering the field of medical imaging for over 60 years. With a strong presence in the US, Canada, and Sweden, we have a global reach and a commitment to innovation. Our company has a revenue of over $1 billion, driven by the success of our imaging agents for cardiac ultrasound and prostate cancer.

Job Summary:

We are seeking an experienced Associate Director Pharmacovigilance to join our Global Pharmacovigilance team. The successful candidate will be responsible for managing business partnerships and coordinating pharmacovigilance activities for developmental products. This role will also oversee pharmacovigilance migrations and transitions related to company or product acquisitions.

Key Responsibilities:
  • Lead interactions with Lantheus' Clinical Research team and pharmacovigilance vendors to ensure all safety reports are processed consistently and compliantly.
  • Provide technical and data management support to ensure information entered and retrieved from the safety database is accurate and complete.
  • Ensure the processing of safety reports is efficient and compliant with reporting requirements.
  • Support the development and maintenance of a dashboard documenting current status of all ongoing studies.
  • Provide guidance and support to study project teams for safety-related areas.
  • Assist with the preparation and updates to Investigator Brochures, IND Annual Reports, and other regulatory documents.
  • Assist with the ongoing review and analysis of adverse event data from ongoing studies.
Requirements:
  • Bachelor's or Advanced degree in a life science, nursing, pharmacy, or other healthcare-related profession.
  • 8+ years of direct pharmacovigilance work experience in the pharmaceutical industry.
  • Experience with ICH E2B-compliant databases and ARGUS is preferred.
  • Solid understanding and working knowledge of US and ex-US pharmacovigilance regulatory requirements.
  • Experience of processing and expedited submission of safety reports is highly preferred.
  • Knowledge of MedDRA and WHO Drug dictionaries.
  • Experience with overseeing and managing vendors.
  • Experienced in pre- and post-approval pharmacovigilance activities.
  • Experienced in partner engagement and compliance management.
  • Solid clinical knowledge and strong analytical ability.
  • Strong proficiency in verbal and written communication.
  • Ability to work independently and manage multiple projects simultaneously.
Core Values:
  • Let people be their best.
  • Respect one another and act as one.
  • Learn, adapt, and win.
  • Know someone's health is in our hands.
  • Own the solution and make it happen.

Lantheus is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating a workplace that is inclusive and respectful of all employees and applicants. If you require an accommodation in connection with the hiring process or to perform the essential functions of the position, please contact our Talent Acquisition team at talentacquisition@lantheus.com.

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