Analyst - PV Case Processing

Veterinarian (equivalent to US DVM degree) with or without pharmacovigilance experience; or Bachelor’s degree in Life Sciences related field with 0-2 years of pharmacovigilance experience.

The Analyst in PV Case Processing is responsible for managing adverse event reports, ensuring data accuracy, and maintaining compliance with global pharmacovigilance regulations and timelines. The role involves data entry, assessing seriousness and causality, and ensuring the completeness and quality of cases for regulatory submission. Effective communication skills, knowledge of regulations, and the ability to manage multiple priorities are essential. The Analyst must demonstrate Elanco core values, adaptability, and commitment to high-quality standards in all tasks.

Adverse Event Case Processing -

• Responsible for data entry, seriousness assessment and causality assessment of adverse event reports in the PV database
• Identifies issues in case processing that may result in a delay in submission and escalates issues to management as appropriate.
• Develop an understanding of pharmacovigilance regulations.
• Comply with internal and external timelines for managing adverse events and product complaint case processing, and case submission processes as appropriate.
• Typical case processing activities include (but not limited to):
  • Validation of data entry against source document(s) and call notes as appropriate.
  • Assessment of adverse event reports for seriousness, reportabilities and causality including reason for assessment.
  • Perform self-review of all data for completeness, correctness and quality.
  • Ensuring that the case is considered complete, accurate, and ready for submission to appropriate regulatory authorities.
  • Determine what, if any, follow-up information is needed
  • Ensure to meet the expected productivity and quality standards.
  • Active participation in team meetings.
  • Perform other duties as assigned.

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