We are currently seeking a Senior Drug Safety Associate to join our growing pharmacovigilance team.

In this role, you will play a key part in the end-to-end processing and quality management of Individual Case Safety Reports (ISCRs), helping to ensure accurate, timely, and compliant safety data across assigned projects.

You will work closely with colleagues across drug safety and related workflows, contributing your expertise to maintain high standards of quality, compliance, and operational delivery.

Key responsibilities include:

Case Processing and Data Management

• Process Individual Case Safety Reports (ICSRs), including all applicable case types, in accordance with project requirements, internal procedures, and applicable regulations.
• Enter and review case information accurately within the safety database, evaluating adverse event information and determining appropriate actions in line with established processes.
• Ensure cases are processed within agreed timelines and prioritisation requirements while consistently meeting project SLAs, quality standards, and productivity targets.
• Perform comprehensive data review to ensure the completeness, consistency, and accuracy of case information.
• Generate appropriate follow-up queries where additional information is required.
• Make required updates to cases that have been demoted or routed back by Quality or Medical Reviewers.
• Address corrections and resolve findings identified internally or externally following case locking

Quality and Compliance

• Conduct thorough self-quality checks before routing cases to the next stage of the workflow.
• Maintain a strong working knowledge of global pharmacovigilance regulations, health authority requirements, and applicable safety reporting standards.
• Ensure all case processing activities are performed in accordance with approved SOPs, project-specific procedures, and quality requirements.
• Support source document preparation, reconciliation, and archival activities as required

Collaboration and Team Support

• Coordinate effectively with colleagues across other workflows to ensure smooth and timely case progression.
• Support team leads and managers with operational activities and project requirements as needed.
• Act as a Subject Matter Expert (SME) for assigned projects, providing review feedback and sharing expertise with colleagues.
• Mentor and support team members through knowledge sharing, coaching, and training to strengthen quality and consistency.
• Contribute to continuous improvement initiatives and take on additional responsibilities as required to support team and project objectives.

• Good command of written and spoken English; additional languages favorable
• Good knowledge of MS Office
• Good understanding of medical terminologies
• Good knowledge of GCP and PV principles and related guidelines and regulations
• Understanding of patient safety