About the position At Annexon Biosciences, we are 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. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and geographic atrophy, we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon, you’ll be part of a team committed to making an impact together. The Director, Drug Safety and Pharmacovigilance will work closely with the relevant Medical Monitors and Clinical Development Lead Physician(s) to facilitate signal detection monitoring, product risk-benefit assessment, and safety assessment activities of investigational products within individual clinical programs and – as applicable – across the portfolio. This individual will be responsible for strategic leadership and medical oversight of assigned Annexon product(s) and will report to the VP of Drug Safety and Pharmacovigilance.

Responsibilities

• Reviews all appropriate safety data from various sources throughout the product development lifecycle.
• Facilitates medical assessment of all safety related data (AEs, SAE, SUSAR, AESI etc.) for assigned product(s).
• Ensures accuracy of case narratives, coding and medical reviews and ensures appropriate queries are raised for a comprehensive medical review by relevant company physician(s).
• Authors/reviews relevant sections of aggregate safety reports and ensures the overall quality of documents.
• Authors, reviews and provides input as applicable for drug-safety related regulatory reports and clinical study documents including Clinical Study Protocols, Informed Consent Forms, Investigator’s Brochures, Integrated Summary of Safety (ISS), MedDRA coding of AEs, product package labeling, Company Core Safety Information (CCSI)
• Responsible for drafting responses to queries from regulatory authorities or health care professionals on safety issues and any legal queries and requests involving safety issues.
• Lead the analysis, identification and reporting or possible trends and concerns regarding compounds and key related products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety.
• Participate in the preparation and provision of PV training as needed.
• Contribute to and participate in the development and maintenance of a positive team-focused company culture
• Represent Drug Safety and Pharmacovigilance on DSMBs
• Participates in inspection readiness activities and preparation as needed.

Requirements

• Advanced degree in Medicine (e.g., MD, DO) with a minimum of 5 years of experience in a Drug Safety and Pharmacovigilance role in a biopharma company.
• A combination of education and experience that may be deemed appropriate for the position as per the hiring manager and the human resources team’s discretion
• A thorough understanding of the global pharmacovigilance regulatory environment with working knowledge of US and EU regulations (e.g. MedDRA, WHODRL), ICH guidelines, and a working understanding of drug safety databases (e.g. ARGUS), effective project management skills, a demonstrated ability to provide critical and timely insight, and analytical problem-solving skills with a broad perspective
• Flexibility and agility to function on various levels of the role as required in a fast-growing environment.
• Demonstrated competence in obtaining, analyzing, disseminating and reporting safety information in compliance with global regulations.

Nice-to-haves

• Experience filing submissions for marketing authorization
• Medical knowledge with the ability to interpret, synthesize, and communicate complex safety data.

Benefits

• flexible work schedules
• remote opportunities
• Shuttle service from BART, CalTrain and the Ferry.
• competitive base salary
• equity participation
• employee stock purchase plan
• comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, and other benefits.