Medical Reviewer Case Processing
Responsibilities:
- Conduct initial assessment and Medical Review of ICSR s into the safety database.
- Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA code, suspect drug, concomitant medications, lab data, medical history, labelling, causality, review narrative and provide Company Causality Comment.
- Review and respond to any queries/comments from the Case Owner in the Safety database
- Train and mentor PV associates on event capturing and general PV conventions as required.
- Acquire and maintain current knowledge of product and safety profiles for products across therapeutic areas.
- Escalate complex case issues on client products to Team Lead/Line Manager.
- To detail any follow-up information that is required and not already noted within the Safety database.
- To provide documentation of the review and case comments in Safety database in Medical Review workflow.
- Maintain good knowledge of databases, regulations, guidelines and SOP s.
- Maintain strong GPVP and GCP knowledge. Following ICH, EMA and FDA guidelines strongly and implementing them appropriately.
- To actively communicate and participate in internal project meetings.
- Participation in internal and external audits/inspections.
- Perform any other drug safety related activities as assigned by the management.
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Qualification:
- Degree in Medicine. PG degree in any discipline is an advantage but not mandatory.
Experience:
- Minimum 8 years of relevant experience in Pharmacovigilance & Drug Safety.
Skills & Knowledge:
- Strong interpersonal and organizational skills to be a good team player.
- High sense of responsibility, dedication, and desire to work under pressure as required.
- Highly service oriented. Previous exposure to corporate environment, pharma and life sciences industry is an advantage.
- Good communication skills. Fluent in English- spoken and written
