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Director, Pharmacovigilance and Risk Management
2 months ago
Vera Therapeutics is seeking a highly experienced and skilled Senior Director, Global Pharmacovigilance to join our team. As a key member of our Medical Affairs department, you 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.
Key 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 pharmacovigilance team by setting clear expectations & providing hands-on leadership, promoting 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.
- Review trends in safety, including in the class of therapeutic, and provide insights as to any developments.
- Advise Leadership on safety matters and provide strategies for addressing and informing on safety matters, including information provided to investors, patients, and physicians.
- Ensure compliance with global pharmacovigilance regulations and guidelines.
- 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, and medical affairs, senior management, regulatory agencies, alliance partners, investigators and KOLs.
- MD and 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 is an equal-opportunity employer. We offer a competitive total compensation package, including an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Our benefits offerings include medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.
