Pharmacovigilance Services Specialist
Designation: Pharmacovigilance Services Specialist
Qualifications:Bachelor of Pharmacy
Years of Experience:7 to 11 years
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What would you do? Prepare and review PSURs as per the Client’s Standard Operating Procedures and Work Instructions.
What are we looking for? •Ability to establish strong client relationship
Roles and Responsibilities: Prepare and review PSURs as per the Client’s Standard Operating Procedures and Work Instructions. • Send the kick-off meeting (KOM) invite to all the contributors along with agenda, PSUR preparation guide, Previous PSUR, Core Data Sheets (CDSs) or reference safety information, previous PSUR assessment report from HA (if any) and dial-in details. • Liaise with CLIENT Drug Regulatory Affairs team and request brand names generic names, country of submission, registration procedure, HA PSUR assessment report (if any), and CDS for reference. • Liaise with relevant stakeholders for the inputs required for the PSUR. • Notify the processing team to process relevant cases as per the PSUR schedule • Coordinate data cleaning process (missing data clearance and send request for stop/ resume book in of cases) prior to final listings generation. • Schedule meetings with CLIENT safety physicians to resolve report related queries. Perform activities as lead author and prepare submission ready draft report. • Perform peer review of draft reports and provide feedback with the duly filled defect tracker. • Capture quality data for metrics reporting. • Completeness and accuracy of source documentation provided by CLIENT for PSUR/AR to be ensured. • Facilitate Client stakeholders review including QC & QPPV review • Shall address all the comments received from all the CLIENT stakeholders including QC reviewer • On-time escalation of any delayed inputs • Archival of all the PSUR related information in dedicated folders on Client Shared Drives
Bengaluru
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