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Fore Biotherapeutics · 2 months ago

Vice President, Safety & Pharmacovigilance

Philadelphia, PA, US

Full-time

Onsite

Director/Executive

15+ years exp

Fore Biotherapeutics is a next-generation precision oncology company focused on developing innovative cancer therapies. The VP, Safety and Pharmacovigilance will lead the safety and risk assessment of the product portfolio, ensuring compliance with health authority regulations and managing the Pharmacovigilance department.

BiotechnologyHealth CareHealth DiagnosticsMedicalOncology

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

Qualification

Medical Degree (MD)Pharmacovigilance expertiseOncology knowledgeRisk management experienceRegulatory compliance knowledgeTechnical writing skillsInterpersonal communicationPresentation skillsProblem-solving ability

Required

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