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PSUR Coordinator

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

Global coordination of periodic safety update reports (PSUR) preparation and 100% Quality Control, review and publishing of global PSUR for the entire Novartis Pharma marketed product port-folio, authoring of safety documents, and maintenance of Standard Operating Procedures (SOP), templates and business guidance and management of compliance with the regulatory requirements. Maintain worldwide compliance of PSUR submissions to HA authorities by delivering high quality PSURs for Novartis Marketing Authorization license obligation1.Maintain assignments and periodicity schedules for Periodic Safety Update Reports (PSURs), PSUR Addendum Reports (ARs), and Bridging Documents (BDs) within Drug Safety & Epidemiology (DS&E). 2.Authoring of safety documents.3.Perform quality control (QC) of complex PSURs as per SOPs/guidelines and provide feedback to authors to ensure quality standards are maintained across the organization. 4.Correction of PSUR comments and individual case reports, as needed.5.Coordinate approval of safety reports by DS&E management, collection, distribution and archiving of relevant documentation (e.g. Certificates). 6.Publish and import approved periodic safety reports in CREDI.7.Coordinate medical complaint contributions to the Annual Product Reviews (APR) to ensure timely input to Quality Assurance department. 8.Support advising to DS&E associates and other line functions such as Drug Regulatory affairs on regulatory requirements.9.Ensure full compliance of all global periodic reports with DS&E SOP timelines and in case of a delay investigate root cause and implement corrective action. Be aware of the global compliance reporting rate. 10.Support writing of PSUR/AR/BD templates and SOPs and update as necessary according to emerging regulatory requirements.11.Support training to authors and ensure other line units are aware of contribution standards for the relevant periodic report. 12.Support writing and maintenance of the supportive SOPs for the authorship of the global periodic reports.13.Maintain and track Health Authority Assessment Reports of Novartis periodic safety reports. 14.Participate in cross-functional teams as needed.15.Provide support as required for regulatory authority inspections and audits. 16.Deputize for the PSUR manager or Global PSUR coordinator. 17.Maintain relevant Key Performance Indicators data and checklist18.Address and response to queries on PSUR related issues. 19.Successful and timely delivery of high quality PSUR to Drug Regulatory Affairs for submission to Health Authorities20.Collation and maintenance of Health Authority PSUR Assessment Reports. 21.Timeliness and quality of deliverables according to established directives. 22.Compliance with Internal and External regulations and procedures.
Degree: M.Pharm. (Pharmacy) | MD/ MS (Medicine) | Ph.D. (Doctorate)

Additional Degree: B.Pharm. (Pharmacy) | B.Sc. (Science) | MBBS

Experience: 3-8


Bio-Statistician | Clinical Research | Data Management/ Statistics | Quality Assurance/ Control
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