Annexon Biosciences is a public, clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, eye and brain. The Company’s pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. The Company’s first product candidate, ANX005, is a full-length monoclonal antibody formulated for intravenous administration in autoimmune and neurodegenerative disorders. The Company’s second product candidate, ANX007, is a monoclonal antibody antigen-binding fragment (Fab) formulated for intravitreal administration for the treatment of neurodegenerative ophthalmic disorders. Based on learnings from its initial trials, Annexon is advancing its current programs while evaluating additional orphan and large market indications. Annexon is deploying a disciplined, biomarker-driven development strategy designed to establish that each of its product candidates is engaging the specific target at a well-tolerated therapeutic dose in the intended patient tissue.
The Director, Global 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 set direction of pharmacovigilance activities for ensuring compliance with all applicable laws and regulations and as appropriate and local and foreign regulatory reporting requirements.
- 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.).
- 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 all 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)
- Ensures awareness and training of appropriate Company personnel and external groups of PV and Drug Safety principles, policies and SOPs; participates in investigators’ meetings to provide training on adverse events reporting as required. Responsible for facilitating responses to queries from regulatory authorities or health care professionals on safety issues and any legal queries and requests involving safety issues.
- Oversees the activities of outsourcing vendors and individuals contracted to perform drug safety and pharmacovigilance activities.
- Assists Medical Director(s) in 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.
- Ensures that all safety reports received from any source are processed and reported according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures.
- Assist in the creation, review and implementation of new SOPs, work instructions, guidelines, documents and other tools pertaining to safety.
- Ensures adequacy of the monitoring of clinical trial safety and monitors site compliance with protocol-specified measures intended to ensure the safety of subjects.
- Participates in inspection readiness activities and preparation as needed.
- Bachelor of Science degree required with a minimum of 8 years of experience in a Pharmacovigilance capacity in a biopharma company in a global clinical trial environment. An advanced degree (M.S., Pharm.D. Ph.D., MPH, BSN+RN) and post-marketing pharmacovigilance experience a plus.
- 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
- Thorough understanding of the drug development process.
- 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.
- Excellent interpersonal and communication skills, organizational and decision-making abilities, and ability to adapt to a dynamic and complex regulatory and business environment while working effectively with multiple global cross-functional teams.
- Residence in the SF Bay Area is preferred.