Job Description

Skill required: Pharmacovigilance Services - Safety Writing
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 PSUR/ PBRER/DSUR/PADER/ Addendum Statement/Addendum to clinical overview/US IND reports/ Aggregate finding safety reports/Local reports/ Cumulative Review/Health Authority requests / Health Authority assessment reports as per the applicable procedural documents on the project. Perform scheduling of reports, and author, peer review, publishing, tracking and management 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/request. Prepare meeting minutes and distribute final minutes with all invitees. Review the information received from contributors and obtain any missing information. Draft aggregate report using clients' 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/ESP signature/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. Obtain signature/approval for the finalized reports as defined in procedural document
What are we looking for? oAbility to establish strong client relationship
Roles and Responsibilities: Prepare/compile the final report and confirm that document is complete, including it contains all the applicable annexes as needed and instructed by client, and then submit the finalized report to client. Notify client (regulatory team) that the final report has been submitted to client and confirm all prepared submission documents are uploaded into client environment. Archive AR-related information in dedicated folders on client shared drives or other electronic repositories (as agreed in the procedural document). Perform HA submission tracking of applicable Aggregate Reports Capture quality data for metrics reporting. Responsible for knowledge sharing, coaching, review and providing feedback of reports processed by the Mentees. Complete all trainings assigned by internal and client on their LMS within due date. oNotify critical and major deviations (referred as Quality Issues) within one business days and minor deviations- three business days to Accenture Quality Management team. Organize, action, and archive the communication received at and sent from AR mailbox appropriately. Share/forward product/document type relevant emails to the appropriate user/owner as required and ensure closure. Management of Accenture personal assigned to the AR function. Oversight on the AR mailbox management Ensure team's delivery of reports within agreed timelines with SLAs and KPIs. Liaising with client or any issue mitigation and troubleshooting. Ensure the retention. Ensure training and mentoring of new associates and documentation of the same. Address any quality related issues and implementation of quality improvement initiatives for the team.
Bachelor of Pharmacy
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