Drug Safety Case Manager

Drug Safety Case Manager

The Role & What You Will Be Doing

The Drug Safety Case Manager works in a collaborative, international environment and is responsible for the end-to-end processing and reporting of serious adverse events (SAEs) and pregnancy cases from clinical trials. The role ensures timely, compliant, and high-quality safety case management in accordance with global regulatory requirements, applicable SOPs, and guidelines. This position also carries the role detail of Clinical Safety Specialist within the cleints Product Safety & Risk Management (PSRM) function.

Every day, we rise to the challenge to make a difference and here’s how the Drug Safety Manager, limited for 2 years role will make an impact:

Individual Responsibilities:

• Perform complete lifecycle management of safety cases including triage, data entry, adverse event coding, narrative writing, quality review, and submission of expedited SAE reports.
• Monitor daily workloads and worklists to ensure appropriate prioritization and compliance with regulatory timelines.
• Identify missing or incomplete data and initiate follow-up activities in collaboration with the Drug Safety Physician.
• Act as the Drug Safety representative in Clinical Trial Team (CTT) meetings for assigned studies.
• Collaborate closely with the responsible Drug Safety Physician on all clinical trial operational activities.
• Support SAE reconciliation activities between clinical and safety databases in cooperation with Data Management.
• Coordinate safety submissions to Regulatory Authorities, investigators, Ethics Committees, and Independent Data Monitoring Committees, as applicable.

Shared Responsibilities:

• Ensure compliance with all Quality System (QS) documents, SOPs, and procedural requirements.
• Contribute to Drug Safety projects and process improvement initiatives.
• Support data migration and data cleaning activities as required.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Bachelor’s degree (required).
• Master’s degree or equivalent (preferred).
• Academic background in Life Sciences (e.g. Pharmacy, Nursing, Biomedical Sciences) required.
• 1–2 years of experience in Drug Safety, Pharmacovigilance, or Clinical/Safety Data Management.
• Strong knowledge of medical terminology and general disease processes.
• Solid understanding of medical and drug coding dictionaries (e.g. MedDRA).
• Excellent organizational, interpersonal, and problem-solving skills.
• Ability to work under pressure and manage short regulatory timelines.
• Knowledge of EU and US safety reporting requirements is an advantage.
• High attention to detail and strong compliance mindset.
• English: Advanced proficiency (written and spoken).