Aggregate Report
Aggregate Report
Posted on :
05-02-2025
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Job Description
Job Title: Aggregate Report
Job Location: Ahmedabad Gujarat India
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level:
Skills:
PSUR PABER Aggregate Report RMPs PADERs DSUR
Authoring of Aggregate reports (PSURs/PBRERs PADERs/Annual Reports/ ACO/ DSUR for
submission to local and other Health Authorities.
Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities.
Authoring of Signal Management Reports.
Performing literature search and validity check for the aggregate reports.
Reconciliation of relevant process trackers.
Extraction and validation of data (RSI Sales previous reports RMP signals).
Generation of Line Listings (LL) from safety database
Providing reliable support for high priority Adhoc activities.
Ensure all the reports are drafted within the allocated timelines.
PSUR PABER Aggregate Report RMPs PADERs DSUR
Authoring of Aggregate reports (PSURs/PBRERs PADERs/Annual Reports/ ACO/ DSUR for
submission to local and other Health Authorities.
Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities.
Authoring of Signal Management Reports.
Performing literature search and validity check for the aggregate reports.
Reconciliation of relevant process trackers.
Extraction and validation of data (RSI Sales previous reports RMP signals).
Generation of Line Listings (LL) from safety database
Providing reliable support for high priority Adhoc activities.
Ensure all the reports are drafted within the allocated timelines.
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Employment Type
Full Time
Key Skills
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