0000089447-Drug Safety Associate
Smith Hanley Consulting Group seeks Drug Safety Associate in Somerset, NJ (and other U.S. locations as needed).
Participate in preparation of Safety sections for NDA and MAA related documents; Review all NDA and MAA related documents; Review and compile adverse event data and produce necessary reports; Perform triage, assign priority to incoming events and classify them according to regulatory reporting; Evaluate cases for seriousness, relatedness, and expectedness according to the protocol, investigator brochure, and/or package insert; Confirm presence of adequate information needed to perform case evaluation; Review clinical study adverse events for accuracy, integrity, and consistency according to project-specific guidelines; Perform electronic or manual coding, as necessary; Review relevant source documents for consistency and verification of adverse event data; Prepare narratives, according to approved template; Adhere to required time lines for completion and adverse event reports; Maintain a thorough understanding and strict adherence to GOP guidelines and regulatory reporting regulations.
Position requires a Bachelor's degree in Life Sciences or a related field, plus five years of experience. Must also have experience in pharmacy practice, clinical or product safety; Exceptional knowledge of medical terminology; Experience with MedDRA coding NDA filing; Experience with MS Office products (Excel, Word and Outlook); Ability to audit to ensure accuracy. Must be willing to travel to client sites as needed.
Must also have authority to work permanently in the U.S.
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inVentiv Health, Inc. is an Equal Opportunity Employer, M/F/Disabled/Vets that values the strength that diversity brings to the workplace.