Head of Drug Safety and Pharmacovigilance
Confidential, Boston, MA, United States
Head of Drug Safety and Pharmacovigilance
About the Company
Accomplished biopharmaceutical company developing innovative drugs
Industry Pharmaceuticals
Type Privately Held
About the Role
The Company is seeking a Head of Drug Safety and Pharmacovigilance to provide strategic leadership and oversight of all safety and PV activities. The successful candidate will be responsible for ensuring compliance with US and global pharmacovigilance regulations, as well as for the operational efficiency and best practices within the PV function. This role involves medical oversight of the PV function, including the review of all cases and the creation and maintenance of a signal detection process. The Head of Safety will also be a key stakeholder in safety analyses, represent PV in communications with health and regulatory authorities, and lead the design and implementation of risk management plans.
Applicants for the Head of Drug Safety and Pharmacovigilance position at the company must have a strong background in pharmacovigilance, with a deep understanding of regulatory requirements and industry standards. The role requires excellent interpersonal, communication, and influencing skills, as well as the ability to lead and supervise a high-performing PV team. A collaborative and proactive approach to problem-solving, a strong learning orientation, and a commitment to science and patient safety are essential. The Head of Safety will also be responsible for developing operating plans, budgets, and resource allocation, and must be adept at working cross-functionally to align with the company's priorities.
Hiring Manager Title Chief Medical Officer
Travel Percent Less than 10%
Functions
Medical Care/Hospital Administration
About the Company
Accomplished biopharmaceutical company developing innovative drugs
Industry Pharmaceuticals
Type Privately Held
About the Role
The Company is seeking a Head of Drug Safety and Pharmacovigilance to provide strategic leadership and oversight of all safety and PV activities. The successful candidate will be responsible for ensuring compliance with US and global pharmacovigilance regulations, as well as for the operational efficiency and best practices within the PV function. This role involves medical oversight of the PV function, including the review of all cases and the creation and maintenance of a signal detection process. The Head of Safety will also be a key stakeholder in safety analyses, represent PV in communications with health and regulatory authorities, and lead the design and implementation of risk management plans.
Applicants for the Head of Drug Safety and Pharmacovigilance position at the company must have a strong background in pharmacovigilance, with a deep understanding of regulatory requirements and industry standards. The role requires excellent interpersonal, communication, and influencing skills, as well as the ability to lead and supervise a high-performing PV team. A collaborative and proactive approach to problem-solving, a strong learning orientation, and a commitment to science and patient safety are essential. The Head of Safety will also be responsible for developing operating plans, budgets, and resource allocation, and must be adept at working cross-functionally to align with the company's priorities.
Hiring Manager Title Chief Medical Officer
Travel Percent Less than 10%
Functions
Medical Care/Hospital Administration