drug safety physician 73 846-dsp-w
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Should you be interested in the above position and wish to apply, please send your application with your CV, quoting the above reference number, to our recruitment team at [email protected]
CTC Resourcing Solutions, 117 Waterloo Road, SW1 8UL, London, UK
Tel.: +44 207 193 9972 www.ctcon.ch [email protected]
Providing Flexible Resourcing Solutions CTC Resourcing Solutions, founded in Basel, Switzerland in 1997, is a specialist staffing organisation based in
Basel, London and Munich, providing flexible resourcing solutions to the pharmaceutical industry across Europe, with contract and permanent placements in clinical development, data management, statistics, regulatory affairs and medical marketing.
For one of our clients, we are currently looking for a
Drug Safety Physician
Reference Number: 73-846-DSP-W Type of placement: Permanent Location: Rotterdam area, Netherlands Main Responsibilities: Medical review in clinical trials, including:
Reviewing Case Report Form (CRF) including checking for the medical consistency of patients data, and issuing comprehensive Data Clarification Form (DCF) to sites;
Reviewing adverse events;
Writing and reviewing narratives;
Providing advice on medical and protocol-related questions, selection criteria, inclusion/exclusion criteria, situations that may require discontinuation of the study, questions concerning patient’s safety;
Identifying and handling safety concerns and protocol deviations and procedures Safety activities in clinical trials, including:
Processing adverse events reports including MedDRA coding, causality and expectedness assessment
Expedited and periodic reporting according to current regulations
Preparing and reviewing safety documents (e.g. SUSAR line listings, DSURs, IND Annual Safety reports);
Preparation and submission of other documents requested by the authorities.
Training of study team members and investigators on safety issues, medical issues, or study procedures Qualifications and Experience:
Medical degree, with several years of clinical and drug development experience
3-5 years of experience in Pharmacovigilance
Good communication skills
Computer proficiency
Fluent in both written and spoken English
Relevant working/residency permit or EU-Citizenship required Our offer:
A competitive salary
The possibility for development and advancement within a dynamic environment
The innovative and stimulating atmosphere of an international environment