Vice President, Drug Safety and Pharmacovigilance

Annexon Biosciences • San Francisco, CA

2d

About The Position

Reporting into the SVP, Regulatory the Vice President, Drug Safety and Pharmacovigilance will be responsible for overseeing and directing Annexon’s portfolio of investigational compounds; building the department function and actively participating in the oversight of patient safety in all clinical trials. The successful candidate will be responsible for executing short-term objectives while developing a long-term vision and strategy for monitoring and protecting the safety of patients receiving Annexon’s novel therapies.

Requirements

• MD, MBBS, DO degree with clinical post-training is 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
• Thorough understanding of global pharmacovigilance regulations, GCP & ICH
• Ability to create and fulfill a vision in a matrix environment and work collaboratively with internal stakeholders across different functions
• Working knowledge of validated drug safety databases and dictionaries (Argus , MedDRA, etc.)
• Extensive knowledge of all types of aggregate safety
• In-depth understanding of the drug development

Nice To Haves

• Neurodegenerative disease, autoimmune and/or ophthalmology expertise is a

Responsibilities

• Ensure PV Medical Safety activities are performed in compliance with all applicable regulations and Annexon standards.
• Collaborate with members of 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
• Manages 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
• Ensure safety issues are communicated to the appropriate stakeholders in a timely
• Author analysis of similar events (AOSE) and individual case comments for
• 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
• Formulate response strategies for safety-related health authority and ethics committee
• 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.

Benefits

• A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
• Shuttle service from BART, CalTrain and the Ferry.
• Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, and other benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees