Analyst - GDPS
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Skills you'll use
What you'll do
- 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.
- Your Responsibilities: -
- 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.
Who can apply
- · Skill in using multiple databases. Ability to support during high volumes and flexibility to work extended hours when required. Self-motivated, flexible, and receptive to changes.
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