Vice President, Drug Safety and Pharmacovigilance

Role Summary

Vice President, Drug Safety and Pharmacovigilance will oversee Annexon's portfolio of investigational compounds; build the drug safety and pharmacovigilance department function; and actively participate in the oversight of patient safety in all clinical trials. The role requires executing short-term objectives while developing a long-term vision and strategy for monitoring and protecting the safety of patients receiving Annexon's therapies.

Responsibilities

• Ensure PV Medical Safety activities are performed in compliance with all applicable regulations and Annexon standards.
• Collaborate with the clinical development team in the development and implementation of clinical protocols, safety management plans, data monitoring committee charters, informed consent form (ICF) risk template language, and safety events.
• Manage internal employees, external contractors and vendors to ensure delivery of quality drug safety and PV activities; selects, develops, trains and evaluates team to ensure the efficient operation of the drug safety function.
• Medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues.
• Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, informed consent forms, final study reports, IB/RSI and other documents.
• Provide timely and sound medical review of individual case safety reports from clinical trials or post-marketing sources as needed.
• Lead the regular review of safety data for assigned products for the identification of new safety signals, in accordance with signal detection practices.
• Assess safety signals and trends and proactively manage any potential safety issues.
• Lead development of Risk Management Plans, implementation and evaluation of their effectiveness.
• Ensure safety issues are communicated to the appropriate stakeholders in a timely fashion.
• Author analysis of similar events (AOSE) and individual case comments for safety.
• Accountable for medical evaluation/interpretation of aggregate safety data of assigned product(s) including signal detection and evaluation, aggregate reports (DSUR, PADER, PBRER/PSUR) and ad hoc safety assessments.
• Maintain knowledge of global regulatory authority regulations including FDA and other major authorities.
• Formulate response strategies for safety-related health authority and ethics committee communications.
• Represent PV in communications with health authorities such as the FDA and EMA.
• Provide guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective.
• Other duties assigned.

Qualifications

• Required: MD, MBBS, DO degree with clinical post-training is required
• Required: A minimum of 10 years of relevant drug safety and/or clinical research/clinical safety experience in the biotechnology/pharmaceutical/CRO industry, including safety leadership
• Required: Thorough understanding of global pharmacovigilance regulations, GCP & ICH
• Required: Ability to create and fulfill a vision in a matrix environment and work collaboratively with internal stakeholders across different functions
• Required: Working knowledge of validated drug safety databases and dictionaries (Argus, MedDRA, etc.)
• Required: Extensive knowledge of all types of aggregate safety data
• Required: In-depth understanding of the drug development process