Associate Safety Case Reviewer

About the role

The Associate Safety Case Reviewer collaborates with the Pharmacovigilance Solutions Production team to analyze and report on safety parameters, ensuring patient safety for our clients’ products. The role supports clinical research activities and aligns with client requirements for case review.

Key responsibilities

• Perform adverse event analysis and processing.
• Prepare safety reports for submission to health authorities.
• Maintain data integrity and promote audit compliance following Good Documentation Practice (GDP) standards.
• Adhere to project timelines with proactive communication with Team Lead and Project Managers.
• Analyze stakeholder complaints related to safety reporting, address them in real time, and collaborate with Project Managers to mitigate risk.
• Complete other tasks assigned by the manager or supervisor.

Required profile

• Knowledge of Common Toxicity Criteria (CTC) and/or MedDRA coding.
• Understanding of Good Clinical Practice (GCP), Good Documentation Practice (GDP), and ICH guidelines.
• Excellent written and oral communication skills in English.
• Ability to work collaboratively in cross‑functional teams.
• Meticulous review and validation of work to ensure strict compliance with SOPs and client specifications.

Required skills

• Microsoft Word
• Microsoft PowerPoint
• Microsoft Excel
• Microsoft Outlook
• EndNote
• PubMed
• Embase
• MedDRA coding
• CTC