Vice President, Safety & Pharmacovigilance

Fore Bio is a next-generation precision oncology company focused on the development of plixorafenib, an investigational, novel, small-molecule, next-generation, orally available selective inhibitor of mutated BRAF. The VP, Safety and Pharmacovigilance will be responsible for leading the safety and risk assessment of the product portfolio at all stages of the product lifecycle, including ensuring compliance with health authority regulations in all aspects of pharmacovigilance case reporting and processing. Essential Duties and Responsibilities: Accountable for providing medical and scientific expertise regarding the safety and risk assessment of the product portfolio at all stages of the product lifecycle. Foresight for the growth and oversight of the Pharmacovigilance department, including building and managing a team of medical professionals (at various levels of expertise) to implement the development strategy and support registrational and post-marketing activities in a compliant and collaborative environment, in accordance with long-term strategic goals. Defines and implements methods for the collection, evaluation, management, and communication of safety data from all sources regarding products in development. Responsible for medical safety deliverables that may be the subject of regulatory inspections, including preparation of medical safety documentation. Manages and reviews/oversees reconciliation SAE data between clinical and safety databases. Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment. Ensures compliance with health authority regulations.