Safety Database Specialist

Year    MH, IN, India

Job Description

Job Summary :

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:
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.


Medpace 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.
Why Medpace? :

When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities. Organic Growth: Medpace is continuing to grow in all areas globally and has built an expansive research campus at its headquarters in Cincinnati, OH. In 2020, Medpace opened a new seven story building that is approximately 250,000 SQFT. In total, the headquarter's campus includes five buildings and approximately 600,000 SQFT. The company also has expanding office locations in Dallas, TX and Denver, CO. Perks ( •vary by location and position •): • On-site fitness center(s)
• Campus walking paths
• Company-sponsored social and wellness events
• Official Sponsor of FC Cincinnati
• Hybrid work-from-home options and flexible work schedule
• On-site Market Place
• Free and covered parking
• Discounts for local businesses
• On campus restaurants and banks coming soon

Awards: • Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
• Recognized by Forbes as one of America's Best Mid-size Companies in 2021
• Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
• Ranked in the top 10 on the 2021 LinkedIn Top Companies list in Cincinnati

What to Expect Next:
A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview. •EO/AA Employer M/F/Disability/Vets•

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Job Detail

  • Job Id
    JD3409478
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Contract
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    MH, IN, India
  • Education
    Not mentioned
  • Experience
    Year