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 for a:
Drug Safety Case Manager 100%
12-month contract based in Basel area.
- Processing of adverse event (AE) reports in compliance with applicable global regulations and Standard Operating Procedures (SOPs) and guidelines;
- Managing AE case reports;
- Completing case processing, such as 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 initiation of follow up requests in collaboration with Drug Safety Physician;
- Daily monitoring of the workflow and work lists to ensure all cases are prioritized and processed as appropriate.
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;
- 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.
Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us.