Senior Director, Drug Safety and Pharmacovigilance

Responsibilities

• Facilitate signal detection monitoring, product risk-benefit assessment, and safety assessment activities
• Provide strategic leadership and medical oversight of assigned products
• Review safety data from various sources throughout the product development lifecycle
• Facilitate medical assessment of safety-related data including AEs, SAE, SUSAR, and AESI
• Ensure accuracy of case narratives, coding, and medical reviews
• Author and review aggregate safety reports and regulatory documents
• Draft responses to queries from regulatory authorities or healthcare professionals
• Lead analysis and identification of possible trends and safety signals
• Represent Drug Safety and Pharmacovigilance on DSMBs
• Participate in inspection readiness activities

Requirements

• Advanced degree in Medicine (MD or DO)
• 8-10 years of experience in Drug Safety and Pharmacovigilance within a biopharma company
• Thorough understanding of global pharmacovigilance regulatory environments (US and EU)
• Working knowledge of MedDRA, WHODRL, and ICH guidelines
• Experience with drug safety databases such as ARGUS
• Demonstrated competence in reporting safety information in compliance with global regulations

Preferred Qualifications

• Experience filing submissions for marketing authorization
• Ability to interpret, synthesize, and communicate complex safety data

Benefits

• Flexible work schedules and remote opportunities
• Competitive base salary and equity participation
• Employee stock purchase plan
• Comprehensive health benefits including medical, dental, and vision
• 401(k) and flexible spending plans
• Shuttle service from BART, CalTrain, and the Ferry

About the Company

Annexon Biosciences is a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye.