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Aggregate Report
Pharmazone
posted 2hr ago
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Flexible timing
Key skills for the job
Job Description
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 Ad-hoc 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 Ad-hoc activities..
Ensure all the reports are drafted within the allocated timelines..
Employment Type: Full Time, Permanent
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based on 24 employees
Flexible timing
Monday to Friday
International travel
Day Shift
Pharmazone Benefits
Health Insurance 
Soft Skill Training 
International Relocation 
Team Outings 
Work From Home 
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