Designation: DSA-I, II, III.
Roles and Responsibilities:
- Process Individual Case Safety Reports received by the case processing department.
- Assist during case triage activities.
- Narrative writing and review.
- Event term selection, review, and coding through the latest MedDRA version.
- Review adverse event information received for completeness and consistency.
- Initiate case follow-up activities/AE query management according to Medical Reviewer guidance.
- Perform initial quality review activities to ensure accurate data entry in the Safety Reporting Portal and drug safety database, as applicable.
- Follow company processes and guidelines for case management and closure activities and adhere to company templates and guidelines for documentation and communications.
- Handle project-specific literature search and review activities.
- Ensure compliance with corporate and departmental standard operating procedures.
- Participate in audits and inspections for global case processing.
- Handle case assignment activities as per line manager guidance.
- Ensure Deviations and CAPAs are followed up on and closed in due time.
- Support line managers by preparing compliance and reconciliation reports.
Why Join Us:
- Opportunity for professional growth and development.
- Collaborative and supportive work environment.
- Make a meaningful impact in a fast-paced and innovative company.
Interested candidates kindly share your resume to hr@mitoconbiopharma.com.
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