- Perform triage during case intake activity
- Confirmation of the accuracy of medical coding of all AE/ SAE and medical cohesiveness of the narrative
- Authors the company causality/case comment (CCC)
- Determination of additional actions required such as additional query to reporter
- Provide medical questions to be included in follow-up attempts
- Support the case processing team for any queries
- Check data entry accuracy, coding consistency and Case completeness
- Re-evaluation and assessment of case reports for seriousness, listed ness and causality of all serious and non-serious adverse events
- Review the narratives and check against the information from routine source documents
- Make corrections and updates as appropriate
- Providing timely feedback (& feedback form) to the associates based on the errors captured in mutually agreed QC checklist while reviewing & correcting the cases
- Initiate follow-up activities to obtain additional information and clarification, as appropriate
- Forward cases for quality review or invalid workflow, as applicable, in the patient safety application
- Submission tracking, review, distribution and reconciliation.
- Daily screening of EV WEB for identifying any potential spontaneous cases from EudraVigilance
- To support Clinical Trial Protocol related activities, Participate in initial, review & final discussion of a new clinical trial protocol with Project Lead
- Ascertain protocol requirements along with other stakeholders
- Decide AE/ SAE reporting approach which includes AE/ SAE template creation, decide & finalize of case management approach including AE/ SAE reconciliations pertaining to applicable clinical trial & communicate to the relevant stakeholders.
- Participate in periodic & ad-hoc meetings & update calls.
- Interact with all third party involved for all activities related to reconciliations activities
- Training the new starters for the role as required
- Prepare monthly & periodic reconciliation reports and presentations.
· Medical review and Quality review of cases according to User Manual, SOPs and relevant data entry instructions
· Medical evaluation of case by performing event assessment, checking the seriousness, labeling & causality assessment
- Medical Doctor (MD) or Board certified Physicians or higher degree etc.
- Basic competence with medical and therapeutic terminology
- Able to work independently, guided by procedures, with appropriate support
- Decisive & problem solving
- Good time management and prioritisation
- Attention to detail