Executive Director, Pharmacovigilance Job at Confidential, Indianapolis, IN

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  • Confidential
  • Indianapolis, IN

Job Description

Executive Director, Pharmacovigilance

About the Company

Innovative pharmaceutical company specializing in brain health disorder treatments and biotechnology.

Industry
Pharmaceuticals

Type
Public Company

Founded
2019

Employees
51-200

Categories

  • Pharmaceuticals
  • Medicine
  • Manufacturing
  • Chemical Products
  • Biotechnology

About the Role

The Company is in search of an Executive Director for Pharmacovigilance (PV) to spearhead drug safety initiatives. The successful candidate will be at the forefront of the company's mission to develop and deliver innovative treatments for brain health disorders. This pivotal role involves leading strategic and operational activities for the PV department, ensuring compliance with global safety regulations, and building a robust PV infrastructure to support the entire product lifecycle. The Executive Director will also be responsible for leading PV contributions to marketing applications and post-market safety surveillance programs, as well as managing PV contractors and overseeing the development of a function to support both development assets and marketed products. Applicants must have a terminal degree in a health care profession and a minimum of 12 years' experience in drug development, with at least 8 years specifically in PV operations within clinical trial and post-marketing environments. The role requires a deep understanding of global pharmacovigilance regulations, experience in writing safety sections for regulatory submissions, and the ability to effectively communicate and collaborate with both scientific and business stakeholders. The ideal candidate will be a strategic leader, capable of bridging the gap between scientific and business participants, and will play a key role in the company's commitment to improving patient outcomes through the development of novel medicines.

Hiring Manager Title
Chief Regulatory and Quality Officer

Travel Percent
Less than 10%

Functions

  • CEO/President
  • Non-Profit Management
Confidential

Job Tags

For contractors,

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