Safety Database Specialist
IN-Navi Mumbai
International Careers
Req #: 11432
Type: Full-Time
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Overview: Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities: * Implementation of routine system configuration including product, study and license in Argus and Argus J; * Assist with creating reports using Oracle Business Intelligence reporting tool; * Resolve safety database-related issues; * Prepare/Execute User Acceptance Testing (UAT) of safety system changes; * Assist in Argus Database Training for new users, as applicable; * Generate outputs from the global safety system in support of periodic safety reports (e.g. DSUR, PSUR and PBRER) ; * Assist in the development of system support related process, SOPs, Work Instructions and manuals and * Support Inspection and Audits. Qualifications: Bachelor's Degree in scientific discipline or Business Informatics or similar area with 1-2 years of directly related experience; Preferred Qualifications: * Work experience in CRO/biotech/pharmaceutical industry. * Experience in Study configurations in Safety Systems. * Experience with Safety Database preferably Argus and Argus J. * Experience in SQL. * Experience in reporting and analytic platforms such as OBIEE. * Strong client service orientation. * Strong consultative problem-solving skills. * Ability to combine technical problem-solving skills with discernment to resolve best business solution.
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