Indegene Pvt. Ltd - Walk-In Interviews for QA on 23rd Jan' 2020 - PHARMA WISDOM

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Wednesday, 22 January 2020

Indegene Pvt. Ltd - Walk-In Interviews for QA on 23rd Jan' 2020

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
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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