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Drug Safety Case Manager: MedFocus
    DRUG SAFETY CASE MANAGER
COMPANY INFO: MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel. Our client is a global, independent biopharmaceutical company discovering, developing and marketing innovative drugs for high unmet medical needs and is seeking to add a Drug Safety Case Manager to their team in South San Francisco, California. RESPONSIBILITIES: • The colleague in this position works in a team-oriented environment and will be responsible for the • overall processing of adverse event information associated with investigational and post-marketed • products. • Process adverse event related information in drug safety database for investigational and post-marketing products, including the writing of narratives, for expedited and non-expedited reports. • Create simple queries using safety database in response to queries from internal and external customers. • Track adverse event information and prepare administrative reports for management. • Assist in developing and maintaining standard global procedures and guidelines for Drug Safety operations. • Review, evaluate and assess adverse event information for regulatory reporting. • Assist in completing regulatory reports, such as Periodic Reports, Periodic Safety Updates, IND Annual Reports, and other reports as needed for regulatory authorities. • Create and generate safety information for internal use, and safety review boards. • Interact with other Drug Safety units in the review, processing, and reporting of safety information. QUALIFICATIONS: • Requires a combination of analytical, organizational and interpersonal skills. • Degree in Pharmacy, Nursing, or related health field, or equivalent training and experience, and at least 2 years of experience in safety data management. • Knowledge of domestic and familiarity with international regulatory safety reporting requirements. • Excellent organizational and problem solving skills, interpersonal skills, and the ability to work under pressure and meet tight timelines. • Good communication skills, both written and verbal • General knowledge of coding thesauri and drug dictionaries MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.
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