Vice President, Head of Pharmacovigilance
About the Company
Expanding biotechnology (BioTech) company
Industry
Biotechnology
Type
Public Company
Founded
2017
Employees
51-200
Categories
About the Role
The Company is seeking a Vice President, Head of Pharmacovigilance to lead the drug safety strategy and operations for its innovative RNA-based medicine portfolio. The successful candidate will be a senior leader responsible for defining and overseeing global pharmacovigilance policies, ensuring regulatory compliance, and providing expert guidance on safety risk management. This critical role involves executive leadership, benefit-risk assessment, safety strategy development, and management of PV operations. The VP will also be tasked with leading and overseeing safety-related components of regulatory submissions, representing the company in discussions with health authorities, and driving innovation in pharmacovigilance technology. Applicants must have an MD, PharmD, or PhD in a relevant field, with a minimum of 15 years' pharmacovigilance experience in the biopharmaceutical industry. Strong expertise in global regulatory requirements, particularly in the context of FDA, EMA, MHRA, PMDA, and ICH, is essential. The role requires a candidate with a proven track record in executive leadership, strategic risk-benefit evaluation, and extensive knowledge of safety profiles in neurology treatments. Experience in leading regulatory submissions, including ISS, NDA, and MAA, and exceptional leadership and communication skills are also necessary. The VP will be expected to build and mentor a high-performing pharmacovigilance team, fostering a culture of scientific excellence, compliance, and continuous improvement.
Hiring Manager Title
Chief Medical Officer
Travel Percent
10%
Functions
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