Assistant Pharmacovigilance Manager

Cipla

6 - 11 years

7 - 10 Lacs

mumbai suburban navi mumbai mumbai (all areas)

Posted:15 hours ago| Platform:

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Skills Required

pharmacovigilance icsr case reviewing meddra case processing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Receipt of cases and their assessment to ensure the information is adequate to qualify the case as ICSR.
Perform data entry of ICSR by assessing the source documents and ensure the information entered in the Argus database is appropriate as per source documents of the complaint received.
Follow up for the information of potential cases as per SOPs if the initial information is inadequate
To review cases processed by the case processors for quality, MedDRA coding, narrative, and overall consistency with source documents, SOPs.
To provide periodic quality improvement feedback to case processor.
To identify areas of improvement in terms of compliance, quality, and productivity.
To escalate instances of repeated case processing errors and non-compliance.
To ensure that regulatory reports are approved and submitted to partners or regulatory authority in appropriate format and within the appropriate timelines.
To ensure that source documents pertaining to regulatory authoritys acknowledgement of ICSRs are archived in Argus.
To ensure on time escalation of IT related issues pertaining to Argus and Axway
Handling of CAPA, Deviation, CR and QMS related activities
Assisting the case reporting team in preparing of covering letters for manual submission of reports
Seeking of Regulatory status and other relevant approvals.
Confirming of batch no details for Cipla Products through SAP System.
To allocate and review the cases for reporting assessment.
Provide product configuration requests for Argus.
To provide support in preparation of Safety Management Plan as required.
Preparation and review of SOPs as applicable.
Complete sign off activity for new reporting associates and documentation as applicable.
Any other task/assignment by department head/section head.
To perform monthly TGA DAEN activity.
To perform the role of a subject matter expert (SME) for all ICSR and reporting related related activities
Complete sign off activity for new Book-in, DE and QR associates and documentation applicable.
Responsible for ensuring submission of cases to Regulatory Authorities within timelines
Respond to reporting queries raised by vendors within timelines.
Analyze performance of the team members and vendor periodically and provide feedback to ensure compliance with organizational SOPs.
To perform compliance manager activities for various countries in EY tool

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