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.