Executive Director, PV Operations & PV Science
About the Company
Innovative biotechnology (BioTech) company
Industry
Pharmaceuticals
Type
Public Company
Founded
2016
Employees
51-200
Categories
About the Role
The Company is seeking an Executive Director for PV Operations and PV Science. The successful candidate will be responsible for the strategic and tactical leadership of Pharmacovigilance activities, ensuring proactive and timely benefit-risk assessments of safety data related to the company's portfolio of therapies. This role involves close collaboration with cross-functional teams, including data management, clinical operations, biostatistics, clinical research, and medical affairs, to develop and execute program-level safety strategies. The Executive Director will also lead Medical Safety Management Teams, oversee safety signal evaluation, and risk management, and provide expert safety review for critical submissions. Applicants must have an advanced degree in a health-related field and a minimum of 10 years' experience in the pharmaceutical industry, with at least 5 years' in a leadership role within cross-functional safety teams. The role requires a proven track record in global drug safety and pharmacovigilance, excellent leadership skills, and the ability to foster strong collaborations with internal and external stakeholders. The Executive Director will be responsible for maintaining compliance with global regulatory requirements, developing and overseeing global SOPs and policies, and leading the department's performance and training. The position demands a candidate with demonstrated scientific, clinical, and analytical skills, and the ability to effectively communicate and manage change.
Hiring Manager Title
Vice President Drug Safety & Pharmacovigilance
Travel Percent
Less than 10%
Functions
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