Drug Safety Case Manager (6447)
The Life Science Career Network
CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a:
Drug Safety Case Manager
for a 12-months contract based in Basel area.
Start date: 1st May – 1st June 2025
In this role, you will work in a team-oriented environment and will be responsible for the processing of adverse event (AE) reports in compliance with applicable global regulations and Standard Operating Procedures (SOPs) and guidelines.
Main Responsibilities:
- Completing case processing, including triaging, data entry, coding of AEs, narrative writing, quality control and submission of expediting AE reports to health authorities;
- Performing case prioritization according to relevant Standard Operating Procedures to ensure timely submission of expediting reports to regulatory authorities;
- Identifying missing information and initiating follow up requests in collaboration with Drug Safety Physicians;
- Performing and overseeing reconciliation activities.
Qualifications and Experience:
- Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
- University degree in life sciences (pharmacy, nurse) or equivalent education in health-related field;
- At least 5 years' experience in safety or clinical data management;
- Knowledge of medical terminology and general understanding of disease processes;
- Solid knowledge of coding thesauri and medical/drug dictionaries;
- Good knowledge of the EU and US safety reporting requirements;
- Fluency in English, both verbal and written.
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