At SGS, you can choose. First of all, out of our various vacancies. However, SGS also gives you another choice. Do you choose to expand or to enrich? We are not only looking for colleagues who can go into depths of their discipline. We are equally as much looking for colleagues who we call ‘connectors', people who can connect our diversity to our services. To each other. And this way, enrich our business. SGS is the world's leading inspection, verification, testing and certification company. We're also the benchmark worldwide for quality and integrity. And that makes us very proud. This can only happen thanks to our more than 90.000 colleagues worldwide, with over 1800 employees in Belgium only. Our employees give 110% of themselves every day, divided over all expertises, branches and cultures. Our coworkers build their own way inside the company, the services and the expertise. SGS Life Sciences carries out all type of services for pharmaceutical and biotechnology companies, from coordination and running of clinical trials with new molecules or techniques on human beings, to support and consultancy on post marketing registration activities. SGS Life Sciences has also expertise in the quality control of pharmaceuticals. We currently have an interesting challenge for a DRUG SAFETY PHYSICIAN (Medical Doctor) Your challenge: Medical Monitoring of Clinical trials Medical review of clinical trial protocols and input Preparation of medical monitoring plan Medical input to internal parties (Feasibility, Data management, Statistics, Medical writing) Answering trial/protocol related questions from investigators, including inclusion/exclusion criteria, use of concomitant and prohibited medications, subject's disease states or pre-existing conditions, adverse events, potential protocol violations/deviations, laboratory and ECG results/alerts, other trial specific investigations Act as 24/7 available medical contact person Medical Review of eCRF (medical consistency of clinical and safety data, identification of any medical issue, medical review of coding) Medical review of clinical study report (CSR) Open and regular communication with sponsors Medical Review of clinical and post marketing safety data Medical review of individual case safety report (ICSR): adverse events (AEs), Serious adverse events (SAEs), adverse drug reactions (ADR) Medical review of listings of safety data Medical input and review of PSUR, DSUR, other benefit risk assessment reports Scientific and medical literature search and medical review of literature results in view of benefit/risk reports Able to summarize medical/scientific reports for inclusion in benefit/risk reports Medical Doctor (MD) At least 1-year clinical experience as a medical doctor or in a medical position in pharmaceutical industry or in a CRO Quality minded; eye for detail and being able to make distinction between main and side issues Respecting budgets and timelines Being able to prioritize issues according to importance Languages: fluent English, both written and spoken Please not we cannot support a work permit procedure. What we have to offer: Were you already considering a next step in your career? Maybe this could be your next step. At SGS you can count on an interesting position where you can take responsibility. Come enjoy our fun team of colleagues and on top of that, we will reward you with a salary package according to your expertise and experience. Do you want to be part of this? We are looking forward to hearing from you! Send us your story... Parties, Data Management, Inclusion, Pharmaceuticals, Attention to detail, Communication, PSUR, Risk Analysis, Protocols, ECG, Support Work, Laboratory Work, AES, Budget, Literary science, Clinical study, ADR, Investigations, Monitoring, Health & Safety, Adverse Events, Clinical Research, Clinical Research, CRO, Medical Writing, Marketing, Medication, Science, Statistics Originele vacature is te vinden op StepStone.be – Maak nu een Jobagent aan op StepStone en vind je droombaan! https://bit.ly/2jPYsZC Vind gelijkaardige jobs, informatie over werkgevers en carrièretips op StepStone.be!
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