Veterinarian Pharmacovigilance Specialist

The Pharmacovigilance Specialist ensures compliance with all relevant regulatory authorities (FDA, USDA-APHIS, EMA, CFIA, etc.) regarding adverse event reporting and product safety. This role involves reviewing, assessing, and approving product/adverse event complaints for BIAH products, ensuring adherence to corporate and regulatory guidelines (including FDA 21 CFR, USDA 9 CFR, and European regulations). Additionally, the specialist may assist PV management in analyzing adverse drug events (ADEs), trending data, and supporting signal detection efforts.

Responsibilities:

• Review and assess adverse event and product complaints for products, ensuring compliance with regulatory requirements.
• Submit relevant adverse events to competent authorities (e.g., FDA, USDA, EMA, CFIA) in accordance with SOPs and applicable regulations.
• Ensure full compliance with pharmacovigilance regulations (FDA, USDA, EMA, etc.) and relevant corporate SOPs, including the timely reporting of adverse events and product complaints.
• Provide support to Pharmacovigilance Management in adverse drug event (ADE) analysis, trending, and signal detection as part of ongoing product safety monitoring.
• Maintain accurate records of adverse events and product complaints, ensuring proper documentation in compliance with regulatory and company standards.

Qualifications:

• DVM or VMD degree from an accredited veterinary college.
• Minimum of 3 years of veterinary practice experience or relevant experience in pharmacovigilance, pharmacoepidemiology, or a related field.
• In-depth understanding of pharmacovigilance regulations and compliance requirements (FDA 21 CFR, USDA 9 CFR, European regulations).
• Strong analytical skills and experience with adverse event analysis, trending, and signal detection.

Associate

Contract

Other

Pharmaceutical Manufacturing