Safety Database Specialist Medpace Clinical Research India

0.0 - 2.0 years

4 - 8 Lacs

Navi Mumbai

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Title Due to our continued growth, we are in need of qualified and focused individuals, like yourself. This is a vital role with our Clinical Safety team whose success relies upon your finely tuned skills and background. If you are ready to make a difference, you must be able to accomplish these tasks: 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. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Posted 2 weeks ago

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Job Opportunity : Argus Support & Config : Noida-135 Ultragenic Research And Technologies

2.0 - 7.0 years

5 - 15 Lacs

Noida

Work from Office

I am sharing with you the details related to the profile and the company below and kindly acknowledge this email with your updated resume: Company website : https://ultragenicglobal.com/ Company LinkedIn Page : https://www.linkedin.com/company/ultragenic/mycompany/?viewAsMember=true Job Description for Argus Config. : Should have good understanding of the Pharmacovigilance/ Health Care domain. Should have excellent knowledge of Oracle Argus Safety/LSMV or other PV/Safety systems. Should have experience in installing/configuration/validation of Argus Safety and customizations. Should have good knowledge of SQL, PL/SQL. Should have experience in configuring reports in Argus Aggregate and Periodic reports. Should have experience in Regulatory Standards like 21 CFR Part 11, ICH, GxP. Should have experience in Argus Business and system configuration. Should be able to provide technical architecture and design as per the user requirements. Should have experience in performing System Integration and User Acceptance testing as part of upgrade/ implementation projects. Should have good understanding of regulations (EU, FDA, MFDS, NMPS, Mexico, Taiwan and Russia). Thanks & Regards, Tripti Kumari Associate Principal - HR tripti.kumari@ultragenicglobal.com

Posted 1 month ago

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