Executive Director, Head of Pharmacovigilance Job at Confidential, Somerville, MA

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  • Confidential
  • Somerville, MA

Job Description

Executive Director, Head of Pharmacovigilance

About the Company

Successful therapeutics company specializing in machine learning-powered biomedicines

Industry
Biotechnology

Type
Privately Held, VC-backed

Founded
2018

Employees
201-500

Funding
$200+ million

Categories

  • Biotechnology
  • Health Care
  • Medical
  • Product Research

About the Role

The Company is in search of an Executive Director, Head of Pharmacovigilance to lead and expand its global safety organization. The successful candidate will be responsible for the end-to-end pharmacovigilance strategy, operations, and compliance across all stages of drug development. This pivotal role involves providing scientific and regulatory oversight of PV activities, managing a team to ensure patient safety, and maintaining regulatory alignment. The Executive Director will also be instrumental in shaping the safety culture and infrastructure of the company, guiding safety input into various clinical documents, and representing the organization in regulatory meetings and inspections. Candidates for this role at the company should have an MD with a minimum of 10 years' experience in pharmacovigilance or drug safety, including 2-3 years in leadership positions. A strong background in GCP, GVP, and global PV regulations is essential, as is expertise in biologics and experience in multiple therapeutic areas, particularly immunology. The ideal candidate will have a proven track record in leading PV teams, cross-functional safety strategies, and experience in regulatory authority interactions. Leadership responsibilities also include driving a culture of scientific excellence, compliance, and patient focus, as well as establishing scalable systems for global PV operations and team growth. The role is suited to a visionary leader with strong organizational, decision-making, and communication skills, who is passionate about the impact of generative biology on the lives of patients.

Hiring Manager Title
Chief Medical Officer of Inflammation & Immunology

Travel Percent
Less than 10%

Functions

  • CEO/President
  • Non-Profit Management
Confidential

Job Tags

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