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Job #02685

About our client Our client is a Health Research Company which provides support to the Pharmaceutical, Biological and related industries. Position Location Senior Level Drug Specialist (Post-Marketing) Maryland Salary Highly competitive package, commensurate with experience Responsibilities 1) Evaluate and analyze drug safety data and prepare summary reports 2) Review, evaluate and edit expedited safety reports for marketed and investigational drugs for FDA submission 3) Investigate and provide reports of adverse drug experiences for marketed and investigational drug products 4) Review and evaluate drug safety data from safety database or clinical study reports in response to client or FDA request 5) Code adverse drug experiences and drugs for clinical trial and postmarketing drug safety surveillance 6) Develop Standard Operating Procedures (SOPs) for drug safety surveillance, adverse event and drug coding, and other activities of the Medical Affairs Department 7) Update or recommend the updating of package inserts of marketed drug products based on new safety information 8) Generate and evaluate trend analysis reports 9) Provide consultation to Medical Affairs staff, Research Operations staff, programmers, clinical study site personnel and clients Requirements 1) Medical degree 2) 5 – 7 years experience in medical/clinical experience along with drug safety monitoring 3) Excellent experience in post-marketing 4) Demonstrated knowledge with Food and Drug Administration (FDA) regulations and guidance, including International Conference Harmonization (ICH) and Good Clinical Practices (GCP) 5) Experience in submissions to the FDA 6) Excellent oral and written communication skills 7) Superb organizational and time management skills along with computer literacy