VP - Global Drug Safety and Pharmacovigilance

October 13

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Apellis Pharmaceuticals

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Targeted C3 Therapies • Complement System • Hematology • Ophthalmology • Nephrology

501 - 1000

Description

• The Vice President of Global Drug Safety and Pharmacovigilance is a safety physician and a key leader in the Global Development Organization. • This role is accountable for overseeing safety and pharmacovigilance across all ongoing clinical trials, expected global launches, and post-marketed products. • This is a highly visible position that will interface across all levels of management and functional areas, providing safety leadership and advisement on various initiatives for the organization. • Lead a multi-disciplinary, global organization responsible to execute and monitor all safety and pharmacovigilance strategies for products at all stages of development and commercialization. • Define strategic Drug Safety and Pharmacovigilance plans and policies. • Lead product safety surveillance strategy and manage the evolving safety profile for Apellis clinical development programs and post-marketed products. • Lead the cross-functional product safety team, including communicating safety issues to senior leadership as needed. • Grow, direct, and support the operations of a global function supporting products from Phase 3 through NDA/MAA filings to approval and post-marketing. • Complete routine pharmacovigilance activities for assigned programs, including the formation of the Reference Safety Information, aggregate safety reporting, signal detection, and literature review. • Create/update the safety/risk sections in protocols, investigator brochures, and informed consent forms. • Develop analysis strategies for the Integrated Summary of Safety (ISS) and benefit-risk content within the Clinical Overview documents associated with regulatory filings. • Coordinate the design, development, and implementation of Risk Evaluation and Mitigation Strategies (REMS) among multiple stakeholders. • Provide advisement on the design of post-approval safety studies. • Facilitate cross-functional collaboration within the organization to ensure proper safety standards are met and communicated. • Be responsible for the medical-safety sections of aggregate safety reports (DSUR, PSUR). • Assist in the successful implementation, execution, and maintenance of safety processes and systems that align with the company’s business strategy, industry standards, and global regulations. • Provide medical safety expertise for the monitoring of clinical trials and data safety monitoring boards.

Requirements

• MD or relevant advanced degree in health science with relevant experience. • 10+ years of experience in pharmacovigilance/drug safety. • Expert knowledge of domestic and international regulatory safety reporting requirements for investigational and marketed products, including FDA/ICH guidelines related to pharmacovigilance (e.g., E2B) and Good Clinical Practices, as well as a working knowledge of the Code of Federal Regulations regarding drug safety. • Demonstrated track record leading Leadership experience with strong track record providing clear direction, removing barriers, and developing talent. • Ability to review, synthesize, analyze, and communicate (verbally and in writing) complex safety data and clinical/pharmaceutical information. • Ability to design, lead and effectively manage a geographically dispersed, multi-functional organization. • Excellent interpersonal skills, with demonstrated abilities to work in a multi-disciplinary setting, foster and nurture teamwork, and act as a facilitator to drive the fulfillment of corporate strategic goals. • Superior written and oral communication skills and the ability to work collaboratively and build relationships with colleagues at different levels of the organization. • Highly motivated with the ability to be flexible in a fast-paced environment.

Benefits

• health insurance with full premium coverage • 401K with company match • paid time off (PTO) • long-term disability insurance • life insurance and more!