Sr Drug Safety Associate
Company: Prowess IT Solutions LLC
Location: East Brunswick
Posted on: January 24, 2023
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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.
recblid lzr3c5p8bp1hx33gwz23p1of2509d6
Keywords: Prowess IT Solutions LLC, East Brunswick , Sr Drug Safety Associate, Other , East Brunswick, New Jersey
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