Vice President, Pharmacovigilance & Patient Safety
About the Company
Established pharmaceutical company
Industry
Pharmaceuticals
Type
Public Company
Founded
2002
Employees
5001-10,000
Categories
About the Role
The Company is seeking a Vice President for Pharmacovigilance and Patient Safety. The successful candidate will be tasked with developing and implementing business strategies to ensure FDA-compliant call center and safety data management systems. This is essential for the effective handling of medical inquiries, customer complaints, and adverse event reports related to both US and ex-US products. The role involves providing strategic development, management, and leadership to guarantee that all activities of the drug safety call center and pharmacovigilance team are in compliance. The Vice President will also serve as the company's pharmacovigilance expert, collaborating with medical and clinical affairs teams to address important drug safety issues and will have oversight of the REMS program for risk management and compliance. Key responsibilities for the Vice President include leading a global pharmacovigilance team, establishing governance and processes for safety signal evaluation, and managing resources to meet development objectives. The role requires collaboration with global patient safety colleagues and representation of the company with various health authorities. The ideal candidate will have a strong background in pharmacovigilance, including experience with safety data exchange agreements, and a proven track record in managing and mentoring staff to ensure high standards of compliance. The position demands a leader who can drive innovation and continuous improvement in drug safety surveillance and is adept at preparing for and managing regulatory inspections.
Hiring Manager Title
Chief Quality Officer
Travel Percent
Less than 10%
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