A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Senior Safety Processing Expert
Job Description:
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 quality
3. 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 needed
5. 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 databased.
6. Drive process changes according to internal and externals drivers
7. Timely provision of monitoring reports 8. Act as Subject Matter Expert during audits & inspections and develop Corrective and Preventive Actions and measure effectiveness
9. Timely release of monitoring reports
10. Develop and monitor process related metrics
11. 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 application
16. 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. Major Accountabilities continued.
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 databased, 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
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Candidate Profile :
Medical Degree (MBBS) or Bachelors Degree in Pharmacy or Advanced Nursing Degree or Masters Degree in life sciences or related fields; or equivalent combination in educational credentials an Good knowledge/fluency in English. Knowledge of other languages desirable. 2-3 years of prior experience in pharmacovigilance. Familiarity with medical terminology.
• Ability to write clearly and concisely.
• Self motivation and proactive stance to work.
• Sense of urgency and commitment for timely completion of activities.
• Prior Medical Transcription or Medical Writing experience preferred.
• Previous data entry experience is desirable.
Additional Information:
Job ID: 201078BR
Location: Hyderabad
Division: Global Drug Development
Business Unit: CMO & PATIENT SAFETY GDD
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: R&D
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