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Medical Review Specialist


  • Zolon Tech Solutions Inc
  • 04/12/19
  • South San Francisco, CA
  • 94080
  • Part-Time
Title: Medical Review Specialist
Duration: 03 Months-Part Time-20 Hours per week
Location: South San Francisco, CA

Duties: Applies advanced knowledge of ARISg and ICSR processing to support and complete medical review in ARISg on behalf of the accountable Safety Scientist/Safety Science Leader. Generate and manage ICSR queries for clinical studies. Review and edit clinical study narratives as requested in support of safety reviews (eg, iDMC), CSRs, etc. Acts as single point of contact for SMTs, as requested by manager, with respect to safety related activities. Assists PD Clinical Operations with ensuring appropriate inclusion of safety reporting information for investigator and site training. Facilitate process for clinical trial reconciliation (as applicable). Review and address deviations in safety reporting sections of protocols vs protocol template; review study specific eCRF, Study Configuration Document (SCD); review and collaborate with Clinical Operations on implementation of protocol specific reporting requirement e.g., for Adverse Events of Special Interest; and ensure corresponding database and reporting processes are in place (e.g., IMP designation, appropriate listing of protocol in ARISg). Contributes to safety reporting sections of periodic reports (e.g., SSR, DSUR).
Skills: ARISg Understanding of operational aspects of drug development and drug safety; Computer proficiency and ICSR data entry experience preferred. Excellent communication skills, both written and verbal.
Education: Minimum Bachelor degree, strong desire Healthcare Professional degree (e.g., RN, BSN, PA, NP, MSN, MD, or PharmD.

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