About the role

Responsibilities:

Identify and manage Individual Case Safety Reports (ICSRs) related to adverse events associated with pharmaceutical products.
Enter data accurately and process cases in the safety database according to client guidelines and standard operating procedures.
Conduct MedDRA coding for adverse events, medical history, and relevant medical terminology, as applicable.
Review case information for completeness, accuracy, consistency, and compliance with safety reporting requirements.
Support the submission of safety reports within applicable regulatory timelines.
Perform follow-ups to obtain missing or additional information required for case processing.
Identify and resolve moderately complex case-processing issues using established procedures and analytical skills.
Maintain accurate documentation and follow quality standards, compliance requirements, and internal procedures.
Coordinate with team members, supervisors, and client stakeholders to support timely case processing and submission.
Contribute to process improvement initiatives and support team deliverables.
Work in rotational shifts as required by business needs.

Requirements:

Bachelor of Pharmacy (B. Pharm) or MBBS.
Understanding of pharmacovigilance, adverse event reporting, and drug safety concepts.
Knowledge of medical terminology and the ability to review medical information accurately.
Attention to detail and analytical problem-solving skills.
Ability to follow standard operating procedures and regulatory guidelines.
Good written and verbal communication skills.
Ability to work collaboratively in a team-oriented environment.

Key Skills:

Medical Reviewer