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Senior Safety Processing Expert


Source:
TIMESJOBS.COM
Location:
Secunderabad, Telangana
Date:
19-11-2016
Job Code:
58329870
Categories:
  • Biotechnology & Science
Applying for this job will take you to an external site
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Job Details

Facilitates safety monitoring by optimizing scientific quality documentation and data entry of Safety case reports for Novartis drugs. Responsible for the receipt, tracking, acknowledging and initialization of single case drug safety reports into the safety database. Responsible for accurate data entry and coding of adverse event reports and evaluation of non-expeditable reports within well defined timeframes, in compliance with DS&E business rules, standard operating procedures and regulatory requirements. Responsible to perform daily quality review (QR) for Individual Case Safety Reports (ICSR) by comparing source documents and the case information entered into the safety database to ensure accurate and consistent data entry/quality. Ensure accurate and consistent coding of medical history, drugs and adverse event terms Assess adverse event reports for seriousness, causality and expectedness as per the Investigator Brochure/Basic Prescribing Information/US package insert, consulting the Medical Safety Expert whenever needed Determine the necessity for follow-up and prepare follow-up request as needed.1. Assess seriousness, causality and labeling of serious adverse events and quality check ICSRs to ensure accurate and consistent Argus data entry from source documents. 2. Evaluation and QC of Serious Adverse Event / Post Marketing Adverse Event to ensure accurate and consistent data entry and processing from source documents, with emphasis on accuracy, timeliness and quality3. Ensure accurate and consistent coding of medical history, drugs and adverse event terms 4. Assess adverse event reports for seriousness, causality and expectedness as per the Investigator Brochure/Basic Prescribing Information/US package insert, consulting the Medical Safety Expert whenever needed5. Determine the necessity for follow-up and prepare follow-up request as needed Work in conjunction with Clinical Safety Associates, Pharmacovigilance Scientist from other processing sites and Medical Safety Physicians to ensure that reports are accurately evaluated and database. 6. Drive process changes according to internal and externals drivers7. Timely provision of monitoring reports 8. Act as Subject Matter Expert during audits & inspections and develop Corrective and Preventive Actions and measure effectiveness9. Timely release of monitoring reports 10. Develop and monitor process related metrics11. Identify and eliminate non-value added processes 12. Develop, contribute and maintain procedural documents and map processes [SOPs, WPs, PGDs, SGDs, FRMs , Training slides, process maps] 13. Lead Impact assessment for environment changes (business or regulatory driven)14. Working in collaboration with the CPOs for local literature screening process 15. Monitoring literature search application and leading changes/ improvements in the existing application16. Author/co-author, along with Global Medical Safety Physicians, regulatory periodic safety reports (Periodic Safety Update Reports, US Periodic Reports) for Novartis mature portfolio collecting, organizing, analyzing and presenting the data by means of DS&E templates and procedures 17. Lead/co-lead cross functional expert teams to fulfill Periodic Safety Report accountabilities (DRA, Clinical, Marketing)18. Review global marketing programs and establish process for AEs collection with global marketing teams. 19. Review Risk Management Plans in coordination with Global Medical Safety groups and assess the operational feasibility and implications of Pharmacovigilance commitments.20. Collaborate with Electronic Data Management team to reconcile Serious Adverse Events between the Clinical and Safety databases to meet joint accountabilities and enable locking of Clinical database. 21. Alert the Medical Safety Physicians of potential safety issues and assist the Medical Safety Physicians in monitoring the safety profile of products.22. Member of Safety Profiling Teams to ensure that case reports are accurately evaluated and database, authoring or contributing to Product Specific Guidelines for assigned products. 23. Support the development and testing of safety systems/IT applications and in the preparation of relevant manuals.24. Support Health Authorities inspections and audits, and development of Corrective & Preventative Actions (CAPA) to address safety findings. 25. Train and mentor new DS&E associates.
Degree: M.Pharm. (Pharmacy) | MD/ MS (Medicine) | Ph.D. (Doctorate)

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

Experience: 2-3

Requirements

Clinical Research | Data Management/ Statistics | Documentation/ Medical Writing | Quality Assurance/ Control
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