Vice President, Pharmacovigilance

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.
• 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.

Pay

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.