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Annexon Biosciences · 3 weeks ago

Vice President, Drug Safety and Pharmacovigilance

San Francisco Bay Area

Full-time

Hybrid

Director/Executive

$363K/yr - $403K/yr

10+ years exp

Annexon Biosciences is a biopharmaceutical company focused on advancing therapies for neuroinflammatory diseases. The Vice President, Drug Safety and Pharmacovigilance will oversee investigational compounds and ensure patient safety across clinical trials while developing long-term strategies for safety monitoring.

BiotechnologyHealth CareHealth DiagnosticsLife ScienceTherapeutics

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

Qualification

Drug Safety LeadershipPharmacovigilance RegulationsClinical Research ExperienceNeurodegenerative Disease ExpertiseAggregate Safety KnowledgeDrug Safety DatabasesVision CreationCollaboration SkillsCommunication Skills

Required

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

Neurodegenerative disease, autoimmune and/or ophthalmology expertise is a

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