Vice President, Pharmacovigilance - Remote

Vera Therapeutics

10yr years

$309,000 to $424,000 per year

Brisbane

10 July 22, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Vice President, Pharmacovigilance

About Us:

Vera Therapeutics (Nasdaq: VERA) is a late-stage biotechnology company dedicated to developing transformative treatments for serious immunological diseases. Our mission is to advance therapies targeting the root causes of these diseases to set new standards of care. Our lead candidate, atacicept, is a fully humanized fusion protein administered subcutaneously once weekly. It blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which are involved in the production of immune complexes fundamental to IgA nephropathy (IgAN). Vera is also exploring atacicept’s potential in other immunological disorders and developing MAU868, a monoclonal antibody targeting BK Virus infections, particularly in kidney transplant settings. For more information, visit www.veratx.com.

Our values guide everything we do, from hiring top talent to advancing our mission and improving patient care.

Position Summary:

The Vice President of Pharmacovigilance will report to the Chief Medical Officer and oversee global drug safety and pharmacovigilance activities. This role will ensure proactive benefit-risk assessments of all safety data related to our therapies, from clinical development through post-marketing. The VP will lead and manage a high-performing pharmacovigilance team and collaborate with Clinical Research and Medical Affairs teams to provide strategic oversight and ensure compliance with global regulations.

Responsibilities:

Lead global clinical safety, pharmacovigilance, and risk management activities throughout the product lifecycle for investigational and marketed products.
Build and manage a high-performing pharmacovigilance team, setting clear expectations and promoting collaboration and team cohesion.
Provide strategic oversight for safety sections of regulatory documents (BLA/MAA/NDA), public presentations, and scientific articles.
Analyze safety trends and provide insights on developments within therapeutic classes.
Advise leadership on safety matters and develop strategies for communication with investors, patients, and physicians.
Ensure compliance with global pharmacovigilance regulations and guidelines.
Provide medical guidance and evaluation of pre- and post-marketing safety data.
Collaborate with cross-functional teams and key stakeholders, including clinical operations, regulatory affairs, quality assurance, medical affairs, and external partners.

Qualifications:

MD with Board Certification in a relevant therapeutic area.
10+ years of experience in pharmacovigilance leadership roles.
In-depth knowledge of global pharmacovigilance regulations and guidelines, including ICH, FDA, EMA, and other regulatory requirements.
Experience in evaluating, implementing, and overseeing pharmacovigilance systems and processes.
Demonstrated understanding of global safety regulatory reporting for investigational and marketed products.
Proven ability to mentor staff and develop skills, foster growth, and ensure a challenging and professional environment.
Strong written and verbal communication skills.
Proactive mindset with a commitment to continuous improvement.
Ability to work independently and handle multiple tasks in a fast-paced environment.
Strong ethical standards.
Ability to travel up to 20%.

Remote Position:

This position offers the flexibility to work remotely.

Compensation:

The anticipated base salary range for this role is $309,000 - $424,000, based on factors including geography, qualifications, skills, and experience. The total compensation package includes an annual performance incentive bonus, equity options, and a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) match, flexible time off, and paid holidays.

Notice to Recruiters/Staffing Agencies:

Recruiters and staffing agencies are not permitted to contact Vera Therapeutics through this page. All recruitment vendors must have a formal written agreement on file. Unsolicited resumes from recruiters will be considered unsolicited, and Vera Therapeutics will not be responsible for related fees.

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Vice President, Pharmacovigilance - Remote

Job Description

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