Senior Specialist, Drug Safety - Animal Health

We are seeking a highly skilled and collaborative Senior Specialist to join our Animal Health Global Pharmacovigilance (GPV) team. In this role, you will contribute as a drug safety expert, participating in safety surveillance, risk assessment, and regulatory compliance for our animal health product portfolio.

Depending on specific portfolio assignments and organizational needs, responsibilities will encompass some or all of the following areas:

• Perform comprehensive review and approval of adverse event cases and ensure timely case submissions to global regulatory authorities.
• Participate in aggregate report and pharmacovigilance statement preparation.
• Provide support to national pharmacovigilance teams.
• Serve as the product expert for assigned products.
• Critically analyze peer-reviewed veterinary literature and clinical study pharmacovigilance data and protocols.

• Participate in signal management activities, including signal detection, prioritization, validation, assessment, and recommendation for action.
• Author Signal Management Statements and, if applicable, submit documentation to Competent Authorities in accordance with statutory timelines.
• Participate in risk communication planning and the development of targeted risk minimization strategies.

• Support product maintenance within the global safety database.
• Provide business support for pharmacovigilance database systems, including reviewing validation documents and executing User Acceptance Tests for functionality changes and system enhancements.

• Actively participate in departmental, cross-functional, and project team meetings.
• Participate in internal audits and external regulatory inspections and support corrective and preventive action completion activities as applicable.
• Support Global Pharmacovigilance procedure management and training initiatives.
• Participate in special projects and initiatives.

• Doctor of Veterinary Medicine (DVM, VMD, or equivalent).
• Minimum of 2 years of clinical veterinary practice experience.
• Strong analytical, communication, and technical writing skills.
• Ability to manage competing priorities within global cross-functional teams.
• Proficiency in Microsoft Office.

• Knowledge of veterinary pharmacovigilance regulations and guidelines
  
  Hands-on experience with safety databases; PV-Works experience is strongly preferred.
• Proven expertise in adverse event evaluation, veterinary safety review, and signal detection methodology.
• Familiarity with veterinary biostatistics, epidemiology, clinical trial data, and audit and corrective and preventive action processes.
• Exposure to modern digital collaboration tools and artificial intelligence applications.

Required Skills:

Adverse Event Report, Collaboration Tools, Compliance Monitoring, Drug Safety Surveillance, Evaluating Applications, Medication Safety, Pharmacovigilance, Product Security, Regulatory Audits, Regulatory Compliance, Risk Management, Risk Mitigation Strategies, Safety Audits, Safety Reporting, Strategic Planning, Team Organization, Training and Development

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