Drug Safety Physician
Drug Safety Physician
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Job Description
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 subjects disease states or preexisting 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
Qualifications :
- Medical Doctor (MD)
- At least 1year 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.
Additional Information :
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 and your resume via the apply button and maybe you will soon join us for work and coffee breaks.
Still have questions
Heidi Aerts can give you more details about the job. Send her an email at
Please only apply via the apply button not via this email address. Thank you.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
