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Vice President, Pharmacovigilance
About the Company
Dynamic biotechnology (BioTech) company specializing in targeted cancer therapies & drug discovery
Industry
Biotechnology
Type
Privately Held
Founded
2017
Employees
11-50
Categories
Electronics
Manufacturing
Pharmaceuticals
Medicine
Chemical Products
Biotechnology
ALK
ALKove-1
ARROS-1
Alectinib
B
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About the Company
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About the Company
Premier healthcare communications agency
Industry
Hospital & Health Care
Type
Privately Held
About the Role
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Vice President of Sales
About the Company
Well-established industrial manufactuer
Industry
Mechanical or Industrial Engineering
Type
Privately Held
About the Role
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Travel Percent
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Job Source: Confidential
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.