Job Description

The Senior Director, Pharmacovigilance Physician will report to the Vice President, Pharmacovigilance and will be responsible for 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 Clinical Research and Medical Affairs teams, 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:

• Serve as Pharmacovigilance lead physician on assigned global clinical safety programs, providing full range of pharmacovigilance and risk management activities throughout the product lifecycle for investigational and marketed products across the pipeline.
• Lead Quarterly Medical Safety Review Committee meetings working in close collaboration with the PV scientist. Able to escalate safety concerns to VP of Pharmacovigilance and to the Medical Safety Review Board following Vera Safety Governance procedures.
• Maintain a high-performing project specific pharmacovigilance team by setting clear providing hands-on leadership, promoting collaboration and team cohesiveness with PV scientist and PV Operations teams.
• Provide strategic oversight for safety sections of all regulatory documents, including BLA/MAA/NDA, public presentations and key scientific articles and abstracts.
• Review trends in safety, including in the class of therapeutic, and provide insights as to any developments.
• Provide review and input to Clinical Trial documents such as CSR’s, Protocols, ICFs, IB’s, Briefing books, CTA’s.
• Advise PV Leadership (VP of Pharmacovigilance and ED of Medical Safety Science) on safety matters and provide strategies for addressing and informing on safety matters, including information provided to patients and physicians.
• Ensure compliance with global pharmacovigilance regulations and guidelines.
• Provide medical guidance and evaluation of all pre- and post-marketing safety data.
• Able to provide analysis of specific safety topics.
• Able to determine and mitigate risk and formulate Risk Management Plans and REMS.
• Collaborate cross-functionally and with key internal and external stakeholders, including clinical operations, clinical development, regulatory affairs, quality assurance, and medical affairs, senior management, regulatory agencies, alliance partners, investigators and KOLs.
• Adding in inspection readiness activities.

Qualifications:

• MD and plus 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 relevant regulatory requirements.
• Experience with evaluation, implementation and oversight of pharmacovigilance systems and processes, including developing quality and compliance metrics.
• Demonstrated understanding of current global safety regulatory reporting requirements for investigational and marketed products.
• 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 independent worker with ability to focus and drive for results.
• Ability to work in a fast paced-environment and to handle multiple tasks.
• Strong commitment to ethical standards.
• Ability to travel up to 20%.

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. For this role, the anticipated base pay range is $311,000 - $356,000. 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.

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.

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