Analyst - PV

At Elanco, an animal health company, the Analyst in PV Case Processing manages adverse event reports, ensures data accuracy, and maintains compliance with global pharmacovigilance regulations. This role involves data entry, assessing seriousness and causality, and ensuring the completeness and quality of cases for regulatory submission.

Key Responsibilities

• 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

• Validation of data entry against source document(s) and call notes as appropriate

• Assessment of adverse event reports for seriousness, reportability's 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

Requirements

• Veterinarian equivalent to US DVM degree with or without pharmacovigilance experience

• M. Pharm with Pharmacovigilance Experience

Preferred Qualifications

• 0-2 years of pharmacovigilance experience