Vice President, Head of 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
Join to apply for the Senior Electrical Power Engineer role at HDR .At HDR, our employee-owners are fully engaged in creating a welcoming environment where each of us is valued and respected. We foster a culture of inclusion and are committed to making a positive impact...
...Why Join Michigan Medicine's Hospital Billing Audits & Appeals (HBAA) Department? The... ...Appeals Specialist has a strong knowledge of medical appeal and audit practices for both the... .... Work Locations Work From Home position or Alternate: Onsite in Ann Arbor...
Tile Installer As a Tile Installer at Brekhus, you will be responsible for the precise installation of tile surfaces on both residential and commercial projects. This includes working with a variety of materials such as ceramic, marble, and granite. Your role will involve...
...Position Summary Reporting to the Chief Medical Officer, the Pharmacovigilance Scientist at Cellectis will manage all activities related to the performance of drug safety at Cellectis. The ultimate objective is to ensure patients, their caregivers, investigators,...
...Quality Engineer The Quality Engineer will evaluate and/or appraise supplier's manufacturing capabilities to baseline their processes... ...+ years of hands-on experience as a Quality Engineering in an Aerospace Manufacturing Environment High School or GED Preferred...