Confidential
Vice President, Safety & Pharmacovigilance
About the Company
Pioneering biotechnology company
Industry Biotechnology
Type Privately Held
About the Role
The Company is seeking a VP, Head of Safety and Pharmacovigilance to play a pivotal role in the organization's commitment to patient safety and the integration of safety into all aspects of the drug development process. The successful candidate will be responsible for leading and building out the safety and risk management function, ensuring strategic oversight and execution of all safety and pharmacovigilance activities, and maintaining compliance with global regulatory standards. This includes establishing a safety and pharmacovigilance infrastructure that prioritizes safety by design, leading safety surveillance, signal detection, and risk-benefit assessments, and serving as the primary contact for safety-related issues.
Applicants must have an M.D., D.O., or M.B.B.S. with a minimum of 10 years of global experience in drug safety within the biotechnology or pharmaceutical industry. In-depth knowledge of FDA safety regulations, ICH Guidelines, EU GVP, and other global safety regulations is essential, as is expert knowledge of safety database applications and signal detection. The role requires strong leadership skills, the ability to mentor teams, and excellent communication skills to influence senior leadership and external stakeholders. The VP, Head of Safety and Pharmacovigilance will also be responsible for managing the pharmacovigilance budget and resources, driving continuous improvement in pharmacovigilance practices, and collaborating with cross-functional teams to integrate safety considerations into the company's strategy.
Hiring Manager Title Chief Medical Officer
Travel Percent Less than 10%
Functions
Medical Care/Hospital Administration
About the Company
Pioneering biotechnology company
Industry Biotechnology
Type Privately Held
About the Role
The Company is seeking a VP, Head of Safety and Pharmacovigilance to play a pivotal role in the organization's commitment to patient safety and the integration of safety into all aspects of the drug development process. The successful candidate will be responsible for leading and building out the safety and risk management function, ensuring strategic oversight and execution of all safety and pharmacovigilance activities, and maintaining compliance with global regulatory standards. This includes establishing a safety and pharmacovigilance infrastructure that prioritizes safety by design, leading safety surveillance, signal detection, and risk-benefit assessments, and serving as the primary contact for safety-related issues.
Applicants must have an M.D., D.O., or M.B.B.S. with a minimum of 10 years of global experience in drug safety within the biotechnology or pharmaceutical industry. In-depth knowledge of FDA safety regulations, ICH Guidelines, EU GVP, and other global safety regulations is essential, as is expert knowledge of safety database applications and signal detection. The role requires strong leadership skills, the ability to mentor teams, and excellent communication skills to influence senior leadership and external stakeholders. The VP, Head of Safety and Pharmacovigilance will also be responsible for managing the pharmacovigilance budget and resources, driving continuous improvement in pharmacovigilance practices, and collaborating with cross-functional teams to integrate safety considerations into the company's strategy.
Hiring Manager Title Chief Medical Officer
Travel Percent Less than 10%
Functions
Medical Care/Hospital Administration