Join a team where your expertise in drug safety plays a pivotal role! Hobson Prior is recruiting for a dedicated Drug Safety Case Manager.
The Drug Safety Case Manager works in a team-oriented environment and is responsible for the processing of adverse event (AE) reports in compliance with applicable global regulations and Standard Operating Procedures (SOPs) and guidelines.
Please note that to be considered for this role you must have the right to work in this location.
Responsibilities:
- Responsible for complete case processing: triaging, data entry, coding of AEs, narrative writing, quality control and submission of expediting AE reports to health authorities
- Perform case prioritization according to relevant Standard Operating Procedures to ensure timely submission of expediting reports to regulatory authorities
- Identification of 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
- Performs or oversees reconciliation activities
Skills and Requirements:
- University degree in life sciences (pharmacy, nurse) or equivalent education in a 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
- Excellent organizational and problem-solving skills, interpersonal skills, and the ability to work under pressure and meet short timelines
- Fluency in English, both verbal and written
For more information, please contact William Tyler.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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