Vera Therapeutics is a commercial-stage biotechnology company focused on the pursuit of truth in science to transform medicine in autoimmune disease, starting with the kidney. Vera Therapeutics’ flagship commercial product is TRUTAKNATM (atacicept-vymj), a B-cell activating factor (BAFF) and A proliferation-inducing ligand
(APRIL) inhibitor. Vera Therapeutics is evaluating multiple diseases where the reduction of autoantibodies through inhibition of BAFF and APRIL may prove clinically meaningful. Vera Therapeutics was founded in 2016 and is based in Brisbane, California. To learn more, visit
www.veratx.com.
At Vera, our values are the cornerstone of our culture and guide how we work together every day. We lead with empathy, act with an owner’s mindset, demand clarity, work without fences, and execute with urgency because patients are counting on us. From how we hire and develop our people to how we advance rigorous science, we are building a team committed to transforming medicine in autoimmune diseases, starting with the kidney.
The Vice President, Pharmacovigilance will report to the EVP, Clinical Development and will be responsible for the development and execution of the company’s global pharmacovigilance and drug safety strategy in alignment with corporate and regulatory objectives. This individual will be providing medical oversight for the global drug safety and pharmacovigilance function to ensure proactive and timely benefit-risk assessments of all safety data, related to our portfolio of therapies. Working with the internal stakeholders across Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, and Commercial functions to integrate safety strategy throughout the product lifecycle this role will provide strategic and tactical leadership and oversee all aspects of Pharmacovigilance activities through all stages of clinical development as well as post-marketing patient safety.
Responsibilities:
- 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.
Qualifications:
- 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.
Strong commitment to ethical standards.
Vera Therapeutics Inc. is an equal-opportunity employer.
Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.
For this role, the anticipated base pay range is$300,000—$420,000 USD
At Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Vera Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.
We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.
Vera Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees.
Fraud Alert
To all candidates: your personal information and online safety are a top priority for us. At Vera Therapeutics, recruiters only direct candidates to apply through our official career page at https://veratx.com/careers/.
Recruiters will always contact you using the domain of veratx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Vera Therapeutics, please email human resources.