- Receive calls/emails related to AE, PQC, MI, and GI.
- Perform case intake, duplicate checks, and registration.
- Follow up on inquiries via phone or email, including translating inquiries if not in English.
- Exhibit detail-oriented etiquette and a friendly attitude when answering calls.
- Escalate calls to a supervisor when necessary.
Training and Compliance
- Ensure timely completion of internal/external training as assigned.
- Participate in/support audits and close CAPAs on time.
- Provide support in other MICC-related activities as required.
Individual Case Safety Report Management
- Data entry of individual case safety reports (all case report types) into the safety database.
- Review and evaluate AE case information to determine required action based on internal policies and procedures.
- Process all cases to meet timelines with defined quality and productivity to meet project SLAs and KPIs.
- Code all medical history, events, drugs/procedures/indications, and laboratory tests according to the appropriate dictionary (e.g., MedDRA, Company Product Dictionary, WHO-DD).
- Write and/or check the correctness and completeness of the medically relevant safety narrative in chronological order.
- Check the completeness and accuracy of data entered in various fields.
- Prepare and archive source documents as required.
- Perform necessary changes in demoted/back routed cases from Quality reviewer/Medical reviewer.
- Review QR feedback and ensure feedback comments are addressed.
- Coordinate with other workflows as required.
- Act as a Subject Matter Expert for assigned projects, providing review feedback, mentoring, and training to enhance quality.
Desired Skills and Experience
- 1-3 years of experience in an MICC role.
- Graduate or post-graduate degree in life sciences.
- Strong communication skills for effective client communication and coordination.
