Vice President, Pharmacovigilance

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee global clinical safety, pharmacovigilance, and risk management initiatives throughout the entire product lifecycle for both investigational and marketed products across the pipeline.

• Develop and lead a high-performing, inspection-ready pharmacovigilance team by establishing clear expectations and delivering hands-on leadership, while fostering operational excellence, collaboration, and team unity.

• Provide strategic direction for safety components of all regulatory documents, including BLA/MAA/NDA submissions, public presentations, and significant scientific articles and abstracts.

• Ensure that robust processes are established for case processing, aggregate reporting, signal detection, benefit-risk assessment, and risk management.

• Offer guidance to Leadership on safety issues and formulate strategies to address benefit-risk dynamics and risk management, including communication with patients, healthcare providers, and regulatory agencies.

• Collaborate with Regulatory Affairs, Clinical Development, and Quality Assurance to guarantee compliance with GVP, GCP, and corporate quality standards.

• Provide medical insights and assess all pre- and post-marketing safety data.

• Work cross-functionally with key internal and external stakeholders, including Clinical Operations, Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, senior management, regulatory bodies, alliance partners, investigators, and key external experts.

⛳️ Requirements

• MD with Board Certification in a relevant therapeutic area.

• Over 10 years of experience in pharmacovigilance leadership positions, including a minimum of 3 years in senior or executive roles.

• Comprehensive understanding of global pharmacovigilance regulations and guidelines, including ICH, FDA, EMA, and other pertinent regulatory requirements.

• Proven track record in establishing or scaling post-marketing pharmacovigilance systems and teams within a small to mid-sized organization.

• Experience in evaluating, implementing, and overseeing pharmacovigilance systems and processes, including the development of quality and compliance metrics.

• Background in mentoring staff at all levels to enhance skills, create growth opportunities, and ensure a professionally stimulating environment that promotes retention.

• Strong written and verbal communication abilities.

• A demonstrated commitment to proactive continuous improvement.

• Highly efficient worker with a proven ability to collaborate across functions to achieve results.

• Strong dedication to ethical standards.

• Capacity to thrive in a fast-paced environment while managing 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 variety of paid holidays.