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Vice President, Pharmacovigilance

Dallas, TX, United States

Vice President, Pharmacovigilance

About the Company

Successful biotechnology (BioTech) company

Industry

Pharmaceuticals

Type

Privately Held

Founded

2007

Employees

11-50

Categories

Biotechnology

Manufacturing

Pharmaceuticals

Medicine

Chemical Products

Academic Research

Laboratory Services

Health Care

Therapeutics

About the Role

The Company is seeking a Vice President of Pharmacovigilance to join their team dedicated to developing innovative medicines for autoimmune and rare diseases. The successful candidate 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 related to the company's portfolio of therapeutic candidates. This role involves leading and managing a high-growth pharmacovigilance team, providing strategic oversight for safety sections of regulatory documents, and advising the Executive Leadership Team on safety matters. The VP will also be tasked with ensuring compliance with global pharmacovigilance regulations, developing the drug safety and pharmacovigilance budget, and leading the process for acquisition and retention of safety vendors.Applicants must have a Medical Degree, with U.S. licensure and Board Certification in a relevant therapeutic area strongly preferred. A minimum of 15 years' experience in pharmacovigilance leadership roles is required, with a minimum of 5 years at the Head of Drug Safety level. In-depth knowledge of global pharmacovigilance regulations and guidelines, as well as experience with drug/device combination products, is strongly preferred. The ideal candidate will have a background in entrepreneurial, small/high-growth company biologics, and experience in a public company, autoimmune, or rare disease setting is a plus. Strong managerial and interpersonal skills, excellent communication, and a commitment to ethical standards are essential for this role.

Hiring Manager Title

Chief Medical Officer

Travel Percent

20%

Functions

Medical Care/Hospital Administration

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