Sr Drug Safety Associate

Company: Prowess IT Solutions LLC
Location: East Brunswick
Posted on: January 24, 2023

Job Description:

Sr. Drug Safety Associate - Prowess IT Solutions LLC - East Brunswick, NJneeded w/ Master's deg. or Foreign Equiv in Biology or Microbiology & Pharmaceutical Science & 1 yr exp as Sr. Drug Safety Associate or Drug Safety Associate performing following job duties: Perform case processing activities (triage, data entry, report distribution) as req'd. Assess, process data & enter all AE case types to meet compliance reqmts. Perform triage on all case types to determine prioritization. Identify adverse events, seriousness, listedness & labeledness for case. Review incoming info to determine reportability. Select the appropriate as reported causality & co. causality. Perform all appropriate coding using MedDRA, WHO-DRUG & Company Product dictionaries. Create narrative text as req'd for medical orientation. Perform CRO case QC activities & reconciliation as req'd. Assign cases using Workflow Mgmt System. Participate in inspections & audits as identified, incl interviews & provision of requested data. Meet KPIs/KQIs as designated in compliance w/ company guidelines & policies. Write late ICSR rltd deviations & CAPAs upon request. Assess matters, propose resolutions & appropriately escalate internally. Provide safety support & clinical site personnel as needed. Set & approve cases for deactivation. Perform generation errors corrections in the case. Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) & project reqmts. Job Locs.: East Brunswick, NJ or unanticipated client sites w/in the U.S. Must be available to travel & relocate to unanticipated client sites for temp. projects. Mail Resumes to: Prowess IT Solutions LLC, 2 Brier Hill Ct, 2B Building F, East Brunswick, NJ 08816.
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Keywords: Prowess IT Solutions LLC, East Brunswick , Sr Drug Safety Associate, Other , East Brunswick, New Jersey