VP Global Pharmacovigilance

Doctor of Medicine or x-US equivalent with industry experience in safety science for oncology clinical development. 12 or more years of experience in the biotechnology or pharmaceutical industry. Knowledge of GCP, clinical trial conduct, data interpretation, and safety in clinical development. In-depth knowledge of clinical research, including FDA and international regulations, clinical study design, and documentation. Experience with early clinical development required; experience in late-stage clinical development and NDA or BLA submission preferred. Extensive experience interfacing with US (FDA) and x-US health authorities required. In depth knowledge of Safety Science and Safety Operations disciplines. Direct management experience with proven ability to effectively lead, coach, mentor, and manage others. Demonstrated ability to achieve high performance goals and meet deadlines. Effective interpersonal, communication and influencing skills, including excellent writing skills.

Provide Safety Science leadership for clinical development programs and teams. Represent GPV in communications with health and regulatory authorities. Provide medical oversight of the GPV function, including medical review of cases. Create and maintain a signal detection process for Erasca’s products. Ensure robust processes are implemented to meet REMS/RMP commitments. Develop and implement Quality Pharmacovigilance (QPV). Provide periodic benefit-risk assessment reports. Contribute to and approve aggregate safety reports for health authorities. Serve as SME for drug-safety related regulatory reports and clinical study documents. Work with external partners to jointly manage cases and signal detection. Manage implementation and/or operation of data analytics and reporting tools. Build and lead highly functioning GPV team, including Safety Operations and Safety Science. Develop operating plans, budgets, and allocate resources. Assess process, systems, and staffing needs for scaling. Develop and maintain relationships across departments.