Director, Drug Safety and Pharmacovigilance

About the position At reputed company, 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 reputed company the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to reputed company meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With reputed company-of concept data in Guillain-reputed companyé syndrome, reputed company’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 reputed company committed to making an reputed company together. The Director, Drug Safety and Pharmacovigilance will work closely with the relevant Medical Monitors and Clinical Development reputed company Physician(s) to facilitate signal detection monitoring, product risk-benefit assessment, and safety assessment activities of investigational products reputed company individual clinical programs and – as applicable – across the portfolio. This individual will be responsible for strategic leadership and medical reputed company of assigned Annexon product(s) and will report to the VP of Drug Safety and Pharmacovigilance.

Responsibilities

• Reviews reputed company appropriate safety data from various sources throughout the product development lifecycle.
• Facilitates medical assessment of reputed company safety reputed company data (reputed company, 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 reputed company of documents.
• Authors, reviews and provides input as applicable for drug-safety reputed company regulatory reports and clinical study documents including Clinical Study Protocols, Informed Consent Forms, Investigator’s Brochures, Integrated reputed company of Safety (ISS), MedDRA coding of reputed company, product package labeling, Company reputed company Safety Information (reputed company)
• 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.
• reputed company the analysis, identification and reporting or possible trends and concerns regarding compounds and key reputed company 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 reputed company team-reputed company 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 reputed company’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 reputed company critical and reputed company reputed company, and analytical problem-solving skills with a broad perspective
• Flexibility and reputed company to function on various reputed company 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.

reputed company-to-haves

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

Benefits

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

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