Walk In for
Associate Quality Assurance-ICSR
Walk in for Associate Quality Assurance role
2 to 3 years experience only on 23rd Jan 2020.
Qualification: Pharm.D and M.Pharm
Experience: 2-3 yrs
·
Pull listing and perform investigations
of late Individual Case Safety Reports (ICSRs) submission to Health Authorities
(HA) and late distribution to Business partners (BP).
·
Initiate initial investigation to
identify lateness reason and responsible organization, follow up with
responsible organization to request lateness reason and CAPA. Validate the
information upon receipt of lateness reason and CAPA, follow up as needed and
enter the data in compliance tool.
·
Perform quality check on the data fields
in the PSR compliance dashboard to check the data completeness and follow up
with responsible organization to resolve discrepancy upon identification of
missing or inconsistent data
·
Perform reconciliation activities to
verify accuracy of the data configurations in client tools
·
Adhering to compliance procedures and
internal/operational risk controls in accordance with any and all applicable
regulatory standards, requirements and policies.
·
Communicate and interact effectively
within and across all client key stakeholders and within internal team
management as appropriate.
·
To attend all the internal trainings and
client trainings and ensure compliance with applicable guidelines.
·
Responsible for all content milestone
deliverables viz- quality and accuracy, timeliness, and efforts.
·
Argus Safety database
·
Root case analyses RCA CAPA
·
ICSRs Quality review of different cases
(Spons, clinical)
·
MEDRA coding
Date: 23rd January from 10 AM
onwards
Venue:
Indegene
Private Limited (SEZ Unit-1 and 2)
Manyata
Embassy Business Park Ground Floor, Aspen Block, G4,
Nagawara
Outer Ring Road,
Bengaluru
560 045
Phone
Number: 080-4674-4567
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