PV Medical Pillar Leader

Role Description
Anticipated role level: Associate Director, Global Pharmacovigilance Medical Pillar Leader

Position Summary
We are seeking a visionary and experienced Global Pharmacovigilance (PV) Leader to oversee and evolve our Global PV Medical Pillar. The Veterinary Pharmacovigilance Medical Leader is responsible for the strategic oversight and operational execution of pharmacovigilance activities related to veterinary products. This role ensures the safety of animal health products through rigorous monitoring, assessment, and reporting of adverse events while maintaining compliance with global regulatory requirements. This role is pivotal in ensuring patient safety and proactive risk management throughout the product lifecycle.

Key Responsibilities

Leadership and Strategy

• Lead the veterinary pharmacovigilance medical pillar function, setting strategic direction and ensuring alignment with corporate safety goals.
• Collective responsibility with Signal Management and Operations Pillar leads for alignment of Global Pharmacovigilance roles, responsibilities, goals, and objectives.
• Represent pharmacovigilance in cross-functional teams, regulatory meetings, and industry forums.

Regulatory Compliance

• Maintain up-to-date knowledge of global veterinary pharmacovigilance regulations (e.g., EMA, FDA, USDA, VICH).
• Ensure global compliance with internal SOPs and external regulatory requirements.

Medical Review and Case Management

• Provide medical oversight.
• Review and approve Periodic Safety Update Reports (PSURs) and Risk
• Management Plans (RMPs)

Team Development

• Mentor and develop pharmacovigilance staff, fostering a culture of scientific excellence and compliance.
• Collaborate with veterinary medical experts, regulatory affairs, and product development teams.

Qualifications

• DVM (Doctor of Veterinary Medicine) or equivalent veterinary degree required; advanced degree (e.g., MSc, PhD) in pharmacology, toxicology, or related field preferred.
• Minimum 8-10 years of experience in veterinary pharmacovigilance or animal health industry.
• Strong understanding of global pharmacovigilance regulations and veterinary product lifecycle.
• Proven leadership experience with cross-functional teams.
• Excellent communication, analytical, and decision-making skills.

Preferred Skills

• Experience with pharmacovigilance databases and signal detection tools.
• Familiarity with zoonotic disease implications and One Health principles.
• Ability to manage complex safety issues and present findings to senior leadership and regulators.
  

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