Vice President, Pharmacovigilance

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Vera Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Vera Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing treatments for immunological kidney diseases that improve patients’ lives. The company is advancing Atacicept through clinical development for IgA nephropathy (IgAN), running Phase 2b and Phase 3 trials, and pursuing programs in lupus nephritis and other immunologic conditions. Headquartered in Brisbane, CA, Vera emphasizes science-driven drug development, patient engagement, and sustainability.

📋 Description

• Lead global clinical safety, pharmacovigilance and risk management activities throughout the product lifecycle for investigational and marketed products across the pipeline • Build and manage a high-performing, inspection-ready pharmacovigilance team by setting clear expectations & providing hands-on leadership, promoting operational excellence, collaboration and team cohesiveness • Provide strategic oversight for safety sections of all regulatory documents, including BLA/MAA/NDA, public presentations and key scientific articles and abstracts • Ensure robust processes are in place for case processing, aggregate reporting, signal detection, benefit–risk assessment, and risk management • Advise Leadership on safety matters and provide strategies for addressing benefit-risk and risk management, including communication to patients, health care providers, and regulatory authorities • Partner with Regulatory Affairs, Clinical Development, and Quality Assurance to ensure full compliance with GVP, GCP, and corporate quality standards • Provide medical guidance and evaluation of all pre- and post-marketing safety data • Collaborate cross-functionally and with key internal and external stakeholders, including Clinical Operations, Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Senior management, regulatory agencies, alliance partners, investigators and key external experts

🎯 Requirements

• MD and Board Certification in a relevant therapeutic area • 10+ years of experience in pharmacovigilance leadership roles, including at least 3 years in senior or executive leadership • In-depth knowledge of global pharmacovigilance regulations and guidelines, including ICH, FDA, EMA, and other relevant regulatory requirements • Demonstrated success in establishing or scaling post-marketing pharmacovigilance systems and teams within a small to mid-sized company • Experience with evaluation, implementation and oversight of pharmacovigilance systems and processes, including developing quality and compliance metrics • Experience mentoring all levels of staff to further develop skills, provide opportunities for growth, and ensure a professionally challenging environment that fosters retention • Demonstrated strong written and verbal communication skills • Proven mindset of proactive continuous improvement • Efficient worker with demonstrated ability to collaborate cross-functionally to achieve results • Strong commitment to ethical standards • Ability to work in a fast paced-environment and to handle multiple tasks

🏖️ Benefits

• annual performance incentive bonus • new hire equity • ongoing performance-based equity • medical, dental, and vision insurance • 401k match • flexible time off • a number of paid holidays