MEDICAL DIRECTOR PATIENT SAFETY
Location: , Nebraska
Description: The Judge Group is at the momment seeking for MEDICAL DIRECTOR PATIENT SAFETY right now, this job will be dwelled in Nebraska. More complete informations about this job opportunity kindly read the description below. Our client is currently seeking a Medical Director. The Medical Director Safety is responsible for safety evaluation and risk management activities for marketed and investigational! products. A minimum of 3 plus years in the biopharmaceutical industry, with 2 years of experience in pharmacovigilance. Prior experience in clinical safety including all phases of clinical development and registration experience with BLA, NDA, or MAA is highly desirable.
The candidate should have demonstrated ability to understand epidemiological data and perform risk assessment analysis of adverse events. As this position includes communication of safety information and analysis within the medical organization in addition to regulatory authorities and the medical community, good communication skills. Demonstrated ability to provide meaningful input to protocol development and interpret clinical data from a safety perspective is highly desirable. Specific experience in clinical epidemiology, drug or vaccine development, public health epidemiology or hospital epidemiology is a plus.
In this role you will function with minimal supervision under the head of ! safety evaluation to handle complex safety issues with a signi! ficant level of independence. This includes leadership and strategic contribution to development risk management plans, and marketed product risk management and pharmacovigilance plans. In this role you will contribute to Medical review of individual case safety reports for assigned marketed and investigational products. Participation in signal detection meetings and work up of possible safety signals identified.
Review of data for possible safety signals and preparation of risk assessment reports. Review and investigation of possible product quality issues in collaboration with the product complaint department. Preparation of aggregate reports, including periodic safety update reports and development safety update reports for products. Patient Safety representative for clinical sub-team for assigned products in clinical development.
Keep patient safety leadership informed of significant marketed product and clinical program safety issues.
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! If you were eligible to this job, please give us your resume, with salary requirements and a resume to The Judge Group.
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This job starts available on: Sat, 22 Jun 2013 04:28:29 GMT
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