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Responsibilities
• Safety expert of the assigned product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities.
• Accountable for the overall safety profile and all product-related decisions and deliverables for assigned products.
• Leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC).
• Product safety profile, benefit-risk evaluation, and risk communication.
• Clinical trial safety Brochure and Informed Consent Form.
• New drug applications and other regulatory filings.
• Risk management and minimization.
• Commercialization Process.
• Inspection Readiness.
• Partnerships and integration activities.
• Participate in safety agreement development and review process.
• Prepare safety information to support licensing partners, review safety documents prepared by licensing partners, and communicate with licensing partners on safety matters per the safety agreement.
Core Competencies
Demonstrates expertise in pharmacovigilance activities, including risk management, benefit‑risk evaluation, and regulatory compliance. Possesses strong leadership skills to guide safety teams and manage partnerships in the bio/pharmaceutical industry.
Requirements
• MD or DO degree from an accredited medical school.
• Completion of an accredited medical or surgical residency OR clinical experience in an accredited academic setting or private practice (including hospital-based) setting.
• 2+ years of industry Global Safety experience.
• Oncology experience in early development.
• Product safety in the bio/pharmaceutical industry or regulatory agency.
• Previous management and/or mentoring experience.
• Experience with oncology products/early development.
