Associate Medical Director - Drug Safety and PV

March 1

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Apellis Pharmaceuticals

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Apellis Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of innovative therapeutic treatments targeting the complement system. The company is dedicated to transforming the treatment landscape for debilitating diseases, with a particular focus on ophthalmology and rare diseases. Apellis is committed to advancing complement science to address unmet medical needs through its robust pipeline of clinical trials and approved products. With a keen emphasis on patient-centered approaches and community engagement, Apellis strives to deliver breakthrough therapies to improve patient outcomes.

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

501 - 1000 employees

Founded 2009

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• The Associate Medical Director, Drug Safety and Pharmacovigilance reports to the Head of Medical Safety Sciences. • Leads global pharmacovigilance for marketed and investigational products. • Oversees safety surveillance, risk assessments, and benefit-risk profile management. • Works closely with cross-functional teams. • Ensures accurate safety evaluations throughout product lifecycle. • Accountable for and leads safety surveillance, risk assessments, and safety management for assigned products. • Supports decision-making through risk/benefit evaluations and safety data analysis. • Collaborates on clinical trials, safety protocols, and patient safety issues. • Supports clinical safety strategy development for Clinical Development Plan and integrated Safety Management Plan. • Oversees Risk Management Plans creation.

🎯 Requirements

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

🏖️ Benefits

• 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. • More!