Associate Medical Director, Drug Safety and PV

Position Summary: The Associate Medical Director, Drug Safety and Pharmacovigilance reporting to the Head of Medical Safety Sciences will lead global pharmacovigilance for both marketed and investigational products, overseeing safety surveillance, risk assessments, and managing the benefit-risk profile. The role involves working closely with cross-functional teams and ensuring accurate safety evaluations throughout the lifecycle of compounds.

Key Responsibilities

Include:

• Accountable for and leads safety surveillance, risk assessments, and safety management for assigned products including timely and thorough safety review as the lead for the Safety Management Team meetings.
• Support decision-making through risk/benefit evaluations and safety data analysis.
• Collaborate with cross-functional teams on clinical trials, safety protocols, and patient safety issues.
• Supports the development of the clinical safety strategy to be included in the Clinical Development Plan, integrated Safety Management Plan and early phase clinical study protocols.
• Working with the Pharmacovigilance Scientist, and relevant cross-functional team members oversees the creation of Risk Management Plans.
• Develop and contribute to safety reports for regulatory submissions and periodic reports.
• Participate in audits, inspections, and maintain compliance with global pharmacovigilance regulations.
• Accountable for providing rapid and effective communication of important safety issues to PV management, with thorough analysis of the issue and proposed mitigation/ management strategies.
• Represents the project team at the enterprise level and for external safety committees and/or Health Authority interactions for issues relating to clinical safety.

Education, Registration & Certification:

• Advanced scientific degree (MD, PHD, PharmD) required, MD preferred.

Experience:

• Minimum of 3 years' experience in industry, with at least 2 years' experience in drug safety (e.g., safety signaling, risk management and mitigation)
• Excellent medical knowledge and safety surveillance experience in nephrology or immunology preferred.
• Thorough understanding of and ability to interpret patient safety and pharmacovigilance data.
• Understanding of drug safety regulatory requirements for investigational products, including ICH, 21 CFR, and EU GVP regulations
• Experienced in safety data analysis, MedDRA coding, and global regulatory guidelines.
• Strong communication and organizational skills, with the ability to work in a fast-paced environment and adapt to changing priorities.
• Ability to collaborate with internal and external stakeholders to manage complex safety issues.
• Strong interpersonal and communication skills
• Ability to interact with all audiences and clearly and concisely present data, strategy and risk assessment.

Physical Demands and Work Environment:

• This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Travel Requirements:

• Up to 20% travel expected.

Benefits and Perks: Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and 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. Apply tot his job Apply To this Job