Senior Director, Pharmacovigilance

Kaztronix LLC; United States; On-site; USD 230,000 - 340,000; Full time

Job summary

Kaztronix LLC seeks a Senior Director, Pharmacovigilance to provide strategic and operational leadership for global pharmacovigilance across development and commercial products. You will oversee safety surveillance, signal management, aggregate reporting, and risk management while partnering with Clinical Development, Regulatory Affairs, and Quality.

The role focuses on building a scalable PV organization, optimizing processes and technology, and ensuring compliance with global PV regulations,

Qualifications

• Advanced degree in medicine, pharmacy, life sciences, or related discipline; MD/PharmD preferred.
• 12+ years of progressive pharmaceutical/biotechnology experience in pharmacovigilance.
• Demonstrated experience leading global PV activities across development and/or commercial products.
• Strong expertise in signal management, aggregate reporting, risk management, PV compliance, and regulatory inspections.
• Proven experience building and leading high-performing teams and managing external PV partners.
• Strong understanding of global PV regulations and GVP requirements.
• Experience optimizing PV processes, systems, technology, and operating models.
• Excellent strategic, scientific, communication, and cross-functional leadership skills.

Responsibilities

• Lead global pharmacovigilance strategy and operations across clinical development and marketed products.
• Oversee safety surveillance, signal detection/evaluation, aggregate reporting, and risk-management activities.
• Provide senior PV leadership to clinical development programs, regulatory submissions, and safety governance committees.
• Ensure compliance with global PV regulations, procedures, and regulatory commitments.
• Lead inspection readiness and support health-authority inspections and audits.
• Build, mentor, and develop a high-performing PV organization and establish scalable operating models.
• Provide strategic oversight of CROs and external PV partners, including governance and performance management.
• Drive process improvement, automation, analytics, and technology-enabled approaches to PV.
• Partner with senior leaders across Clinical, Regulatory, Medical Affairs, Quality, and other functions to translate safety data into actionable decisions.
• Communicate complex safety issues and recommendations effectively to executive leadership.

Job description

Senior Director, Pharmacovigilance Position Summary The Senior Director, Pharmacovigilance will provide strategic and operational leadership for global pharmacovigilance activities across development and commercial products. This individual will lead safety surveillance, signal detection and management, aggregate reporting, risk management, compliance, and inspection readiness while partnering closely with Medical Safety, Clinical Development, Regulatory Affairs, Quality, and other cross-functional teams. The role will also help shape the PV organization's operating model, capabilities, technology, and external partnerships as the portfolio grows.

Key Responsibilities

• Lead global pharmacovigilance strategy and operations across clinical development and marketed products.
• Oversee safety surveillance, signal detection/evaluation, aggregate reporting, and risk-management activities.
• Provide senior PV leadership to clinical development programs, regulatory submissions, and safety governance committees.
• Ensure compliance with global PV regulations, procedures, and regulatory commitments.
• Lead inspection readiness and support health-authority inspections and audits.
• Build, mentor, and develop a high-performing PV organization and establish scalable operating models.
• Provide strategic oversight of CROs and external PV partners, including governance and performance management.
• Drive process improvement, automation, analytics, and technology-enabled approaches to PV.
• Partner with senior leaders across Clinical, Regulatory, Medical Affairs, Quality, and other functions to translate safety data into actionable decisions.
• Communicate complex safety issues and recommendations effectively to executive leadership.

Qualifications

• Advanced degree in medicine, pharmacy, life sciences, or related discipline;MD/PharmD preferred.
• 12+ years of progressive pharmaceutical/biotechnology experience in pharmacovigilance, drug safety, or medical safety.
• Demonstrated experience leading global PV activities across development and/or commercial products.
• Strong expertise in signal management, aggregate reporting, risk management, PV compliance, and regulatory inspections.
• Proven experience building and leading high-performing teams and managing external PV partners.
• Strong understanding of global PV regulations and GVP requirements.
• Experience optimizing PV processes, systems, technology, and operating models.
• Excellent strategic, scientific, communication, and cross-functional leadership skills.

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws. By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.