Case Specialist for Clinical Trial Cases
Skills
About the role
This is a pharmacovigilance case processing role for clinical trial safety cases at ProductLife Group, open to candidates in India with remote work possible. It suits a doctor or pharmacist with hands-on experience in ICSR processing, medical evaluation, and drug safety databases. The role sits within the company's Safety and Vigilance function under the Life Cycle department.
What you’ll do
- Perform quality control of pharmacovigilance and vigilance cases
- Conduct medical evaluation of safety reports
- Process and enter vigilance case data into client-approved systems
- Perform medical coding and causality and seriousness assessments
- Review documents prepared by Data Managers and Vigilance Associates
- Support closure of vigilance and safety files
- Review inclusion and exclusion of EV/MHRA cases
What they’re looking for
- Doctor or pharmacist by training
- Minimum 4 years of experience performing quality control of safety cases
- At least 3 years processing clinical trial cases
- Experience with Oracle Argus Safety or SafetyEasy databases
- Knowledge of current pharmacovigilance regulations
- Professional communication skills in English
Nice to have
- Professional communication skills in French for business continuity
- Experience with electronic case management systems
What’s on offer
- Remote work possible depending on business and operational needs
- Permanent employment
Questions about this role
Is this role remote?
Remote work may be possible depending on business and operational requirements; the job location is listed as India.
How many years of experience do I need?
A minimum of 4 years working with service providers on QC of safety cases, including at least 3 years processing clinical trial cases specifically.
Do I need a specific qualification?
Yes, candidates must be a doctor or pharmacist by training.
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