VP, Global Drug Safety & Pharmacovigilance

Position Summary

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.

Responsibilities Include

• 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.
  
  

Education, Registration & Certification

• MD or relevant advanced degree in health science with relevant experience.
  
  

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.
  
  

Skills, Knowledge & Abilities

• 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.
  
  

Travel Requirement

• Up to 25% travel expected.
  
  

Benefits And Perks

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more! Visit https://apellis.com/careers/ to learn more.

Company Background

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.

For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn

EEO Statement

Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.

For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.