Pharmacovigilance Services Analyst

Skill required: Pharmacovigilance Services - Pharmacovigilance Drug Safety Surveillance
Designation: Pharmacovigilance Services Analyst
Qualifications:Bachelor of Pharmacy/Master of Pharmacy/BSc. Nursing
Years of Experience:3 to 5 years

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What would you do Authoring and peer review of different types of aggregate reports in line with the applicable process.Management of the Affiliate Mailbox reconciliation of reports per process and performance of all written follow up attempts to include both Serious and Non serious casesKOM, minutes preparation, inputs request, drafting, formatting, report finalization
What are we looking for Prepare and review PSUR or PBRER, DSUR, PADER, Addendum Statement, Addendum to clinical overview, US IND reports, Aggregate finding safety reports, Local reports, Health Authority requests as per the applicable procedural documents on the project.
Roles and Responsibilities: Prepare and review PSUR or PBRER, DSUR, PADER, Addendum Statement, Addendum to clinical overview, US IND reports, Aggregate finding safety reports, Local reports, Health Authority requests as per the applicable procedural documents on the project.Perform scheduling of reports, and author, peer review, publishing and tracking activities of assigned reports.Perform request for inputs activity for the reports (based on the RFI (request for information) and as per the applicable process and SOPs).Send the case closure request and request for Line Listings, Summary Tabulations as applicable.Initiate, organize, and lead the strategy meeting for evaluation of safety topic or request. Prepare meeting minutes and distribute final minutes with all invitees.Review the information received from contributors and obtain any missing information.Draft the aggregate report using applicable templates including analysis of safety, clinical and other global line function data. Summarize literature information for applicable reports.Perform peer review of the draft report.Share the draft for quality review.Address the comments from the peer reviewer, quality reviewer and incorporated into the report.Share the draft report with client (or external) stakeholders for review (as applicable).Incorporate and address the comments from stakeholders into the draft report and seek clarification where applicable.Schedule meetings with project safety physicians to resolve report related queries and prepare submission ready draft report.Perform final peer review of draft reports and provide feedback with the duly filled defect tracker.Share the final draft along with the QC scorecard results to client (as applicable).Obtain Client or ESP signature or approvals for the finalized report.Complete and finalize report according to the procedural document requirements.Ensure compliance of finalized report with applicable process and SOPs.


Qualification
Bachelor of Pharmacy,Master of Pharmacy,BSc. Nursing