VP, Drug Safety and Pharmacovigilance

Company Summary

Annexon (Nasdaq: ANNX) is a clinical-stage biopharmaceutical company seeking to bring game-changing medicines to patients with classical complement-mediated diseases of the body, brain and eye. The classical complement cascade is a seminal pathway within the immune system that anchors and drives a host of autoimmune, neurodegenerative and ophthalmic diseases. Annexon is advancing a new class of complement medicines targeting the early classical cascade and all downstream pathway components that contribute to disease, while selectively preserving the beneficial immune functions of other complement pathways. Annexon is rigorously developing a pipeline of diversified product candidates across multiple mid- to late-stage clinical trials, with clinical data anticipated throughout 2023 and beyond. 

Work Location:  Hybrid - Remote assignment will be considered

Position Summary

Reporting into the SVP, Regulatory, Quality and Pharmacovigilance, 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.  

 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 adjudication.
• 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 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 ICSRs.
• Accountable for medical evaluation/interpretation of aggregate safety data of assigned product(s) including signal detection and evaluation, regulatory safety reports (DSUR, PADER, PBRER/PSUR) and ad hoc safety assessments.
• Maintain knowledge of global regulatory authority regulations including FDA and EMA.
• Formulate response strategies for safety-related health authority and ethics committee requests.
• Represent PV in communications with health authorities such as the FDA.
• Provide guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective.
• Other duties as assigned. 

Key Qualifications 

• 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 experience.
• Thorough understanding of U.S. pharmacovigilance regulations, GCP & ICH guidelines.
• 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 plus.
• Working knowledge of validated drug safety databases and dictionaries ~ ARGUS, MedDRA, etc.
• Extensive knowledge of all types of aggregate safety reports.

Annexon Biosciences requires that all employees be fully vaccinated against the Covid-19 virus. An applicant is considered fully vaccinated two weeks after their second dose in a 2-dose series, such as the Pfizer or Moderna vaccines, or two weeks after a single-dose vaccine, such as Johnson & Johnson’s Janssen vaccine. You will be required to show proof of vaccination status upon hire. The Company provides reasonable accommodations in accordance with applicable state, federal and local laws.

DIVERSITY, EQUITY, INCLUSION, BELONGING ARE IMPORTANT TO US 

We believe that diversity, equity, inclusion and belonging are essential for the strength of our business and the vitality of the communities we serve.

Internally, we want to make sure all employees feel welcome, appreciated and can be themselves at Annexon. We continually educate, inform and hold accountability for improving our diversity, equity, inclusion and belonging efforts. We ensure that open and real dialogue happens on important diversity topics.

Externally, we continuously work to build our pipeline of underrepresented candidates for our workforce, enhance, recruit and develop a best-in-class, diverse, equitable and inclusive workforce; ensure that Black, LatinX and other underrepresented businesses have long-term sustainable opportunities to work with Annexon; and hold our vendors to the same standards under which we operate.

The anticipated starting salary for is this position is $305,977.50 to $339,975 per year. The starting salary for this position will be determined based on the candidate’s education, experience, transferable skills, licenses/certifications, location, and will be reviewed on a case-by-case basis to determine the final compensation. The starting salary does not include any other potential components of the total compensation package, including bonus, equity, employer provided benefits, and perks.

Annexon Biosciences is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment based on race, color, religion, national origin, age, gender, sex, ancestry, citizenship status, mental or physical disability, genetic information, sexual orientation, veteran status, or military status. We are proud to promote a work environment where everyone, from any background, can do their best work.”

Annexon Biosciences doesn't accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn't have a signed agreement with Annexon Biosciences.