What are the responsibilities and job description for the Vice President, Safety & Pharmacovigilance position at Fore Biotherapeutics US Inc?
Role Summary:
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. Ensures applicable review and oversight of Pharmacovigilance systems in all aspects, including database, SOPs, training and compliance, and audits and activities performed by vendors.
- Responsible for medical safety deliverables that may be the subject of regulatory inspections, including preparation of medical safety documentation, and follow-up activities such as responses and CAPA development and implementation.
- Responsible for the aggregate review of data for safety signal detection. Performs/oversees signal detection activities and provides written reports to Senior Management. Develops and implements risk management plans in accordance with regulatory requirements. Collaborates with Nonclinical and with Clinical to better assess and understand safety profiles and to prepare safety surveillance activities. Author aggregate reports and benefit/risk assessments.
- Medical expert responsible for safety in the following documents: regulatory responses, Investigator’s Brochure (IBs) including the development of the reference safety information (RSI); standardized safety language for informed consent forms (ICFs), study protocols, and other pharmacovigilance related documents (e.g. DSUR).
- 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 adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
- Ensures compliance with health authority regulations in all aspects of PV safety operations, case processing and reporting; tracks compliance of expedited safety reports in relation with Pharmacovigilance vendors.
Education and/or Work Experience Requirements:
- Medical Degree (MD) with outstanding relevant experience. Possess a minimum of 15 years experience in pharmaceutical/ biotech with risk management and Pharmacovigilance (safety signal detection, data mining techniques, pharmacovigilance databases, etc.); expertise in Oncology preferred
- Expertise in international regulations governing drug safety
- Extensive knowledge of regulatory and compliance requirements governing clinical safety, as well as overall understanding and knowledge of NDA and global filing requirements.
- Proven track record in creating and sustaining a leading‐edge, high quality Pharmacovigilance function within the complex global regulatory-pharmacovigilance environment.
- Proven prior experience with guiding Safety & Pharmacovigilance team through NDA and commercialization.
- Ability to comprehend and synthesize complex data and experience in the identification, analysis and implementation of programs and procedures required to achieve corporate objectives.
- Demonstrated ability to recognize and anticipate problems and proactively resolve them. Strong track record of enjoying the details without losing sight of the larger goals. Ability to multi-task and handle multiple projects simultaneously.
- Excellent technical writing, oral, presentation, and interpersonal communication skills and ability to present concepts and results in a clear and concise manner.
- Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.
Fore is an Equal Opportunity Employer. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic