Hobson Prior are currently seeking for a Drug Safety Specialist to join a brilliant biotech organisation on a permanent basis located in Munich with hybrid working available, ideally able to start in January 2024. Our client is focused on developing a safe and effective immune therapy.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this role, you will monitor finished safety documentation within internal trial master file.
• Supervise workflow for day-to-day PV operations, uphold trackers for all the SUSAR and SAE cases received suitably file within internal SharePoint.
• Evaluate SAE reconciliation data sent by CRO.
• Assist with preparing annual reports when required.
• Responsible for safety evaluation of adverse event reports in CIOMS for precise coding MedDRA, recognise missing or discrepant information and mediate with CRO to query for finishing SAE report.
• Oversight of drug safety mailbox and respond to queries raised by CRO or site as when suitable.
• Monitor timelines for SUSAR cases and mediate with CRO to guarantee proposals submitted in a timely manner.
• Any other assigned duties.

Requirements:

• Educated to a degree level in a pertinent discipline, for example: pharmacology, toxicology, or biomedical science.
• Demonstrable experience within drug safety or a linked discipline, for example: pharmacovigilance or clinical research.
• Comprehension of regulatory guidelines, for example@ those set by the FDA, EMA, and any other national regulatory agencies.
• Familiarity within managing SUSAR evaluations.
• Acquaintance with clinical trials, ideally within CRO and bio-pharma facilities.
• Prior involvement within safety evaluation, data entry, and QC.
• A high attention to detail to guarantee all safety-linked actions are performed suitably.
• Fluency in the English language with knowledge in German would be advantageous.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this 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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