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Company Contact Info
- Summit, NJ
- Erica Geurtse
- Phone: 732-650-3008
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Joule • Summit, NJ
Posted 25 days ago
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Joule, a System One division is seeking a Medical Reviewer for a contract position. With more than 6,000 employees and roughly 40 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
The Medical Reviewer will:
- MD or MBBS required
- Two (2) years relevant medical experience minimum, post-graduation
- Independent decision making and ability to influence required
- Excellent written and oral communication skills in English required
- Computer proficiency required, including database and MS Office Suite products
- Two (2) years pre- and post-marketing drug safety experience preferred
- Knowledge of medical aspects in drug safety preferred
- Working knowledge of MedDRA, WHO-DD is strongly preferred. Knowledge of clinical data management processes is preferred
- Knowledge of global PV regulations preferred
- Execute the medical review of individual case safety report (narrative, coding, labeling, independent company causality assessment, pharmacovigilance comment) and manage corrections with assessment as applicable
- Ensuring medical accuracy of all aspects of the Case Management group’s output
- Ensuring internal escalation and communication of ICSRs to Lead Product Safety Physician for cases of special interest or SUSAR reports from clinical trials and generate discussions with relevant parties (Safety Science, Trials Safety Staff) if required
- Confirm SUSARs and IND Safety Reports
- Manage unblinding of ICSRs from double blinded studies
- Create search criteria, generate report and prepare Analysis of Similar Events (AOSE)
- Contribute to solving reconciliation coding issues/discrepancies
- Review and update generated follow-up letters as appropriate
- Review daily line listing of serious cases and manage corrections with Assessment as applicable
- Communicate with Lead Medical Reviewer for cases of special interest or SUSAR reports from clinical trials and generate discussions with relevant parties (Safety Science, Trials Safety Staff) if required
- Present cases of interest to GDSRM peers during Safety Management Team/therapeutic area meetings as required.
- Contribute to the resolution of issues from cases of high complexity through medical expertise and team interactions
- Manage review of cases according to internal timelines
- Provide input to aggregate reports including PSURs as required
- Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, mandates
- Participate in product review meetings.
Location: Summit, NJ
Duration: 5/11/19 (potential to convert permanent)