Drug Safety Job Opening in Saint Paul at ITvorks

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To help these companies imaginative and prescient vision, and also the Association comes legitimate; ITvorks will be open regarding fresh place seeing that Drug Safety throughout Saint Paul begin as February 2017. Everybody who’s thinking about completing this kind of nonincome producing, you should engage in this particular Drug Safety February 2017 recruitment within Saint Paul. It really is recommended to organize for all members, the many essential just for this employment recruitment method, to give for the reason that the method need someone with the appropriate standards, which the organization would like to through this situation. If you are, you a, you may load the options that you can try to see other information about Drug Safety February 2017 in Saint Paul below.

Drug Safety at ITvorks in Saint Paul February 2017

This position encompasses a key role in executing departmental strategy and the day-to- day functions of Medical Safety (MS) Operations. This role collaborates with colleagues and vendors including MS Science, MS Excellence, Clinical Science, Clinical Operations, Biometrics, Regulatory Affairs (RA), Quality Assurance (QA), and Legal. This is a 12 month project with a strong possibility for extension.

Essential Duties/ Responsibilities-:

  • Performs internal activities and oversight of outsourced activities for ICSR processing and reporting from all sources in compliance and quality according to company procedures and regulatory requirements.
  • Ensures that expedited and periodic safety reports to regulatory agencies and license partners are submitted and compliance is tracked.
  • Liaises with assigned Clinical Reviewer to ensure that appropriate review and assessment is provided for ICSRs.
  • Safety data extraction and production from MS systems for internal partners and regulatory submissions
  • Performs receipt and submission reconciliation between license partners and vendors and serious adverse event (SAE) reconciliation between the clinical and safety databases.
  • Collaborates with QA on product complaints associated with ICSRs.
  • Supports regulatory agency interactions (both written and verbal), inspections, and

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Requirements-:

  • Minimum 3 years of drug safety, clinical research, or healthcare related experience preferred
  • Minimum of 2 years direct pharmaceutical industry experience dealing with global clinical study safety processing and reporting preferred; post-approval safety experience highly desired 2
  • Detailed knowledge of relevant US, EU, and ICH guidelines, initiatives and regulations governing both clinical studies and post-approval safety

Education/ Training-:

  • Bachelor’s degree in life sciences, PhD, PharmD, BSN/RN preferred.
  • Safety database experience required; Argus preferred
  • Proficient in MS Word, Excel, PowerPoint, Outlook and other applicable business software tools.

Job Type: Contract

Salary: $40.00 /hour

Required education:

  • Bachelor's

If you are interested and qualified to follow the job recruitment, you have to prepare yourself and send your application letter immediately. Only candidates who meet the criteria for Drug Safety in Saint Paul, Saint Paul who will be called to attend interview. If you still do not satisfy with our job recruitment information above, you can try to read other job recruitment information that we provide in our website which still located in Saint Paul region from any other company. You can also try to find other job recruitment information for Drug Safety in Saint Paul below.

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