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Senior PV Associate

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

Job Purpose (State in one sentence the overall objective of the role)Responsible for leading worldwide E2B deployment for Individual Case Safety Reports (ICSRs) expediting to Health Authorities and Global License Partners, and quality review of ICSRs and periodic safety reports in compliance with DS&E business rules, standard operating procedures and worldwide regulatory requirements. Major Activities (Describe main activities)1. Lead worldwide E2B deployment in coordination with PVSDM to comply with national regulations a. Coordinate the distribution, review and archiving of Computerized System Valida-tion documentation e.g. executed test scripts, administration of training lists, ac-count request forms.b. Train Country Pharma Organizations (CPO) on E2b activities c. Manage, review and approve E2b proficiency tests.2. Contribute to the preparation of periodic safety update reports (PSURs) and related safe-ty documents to ensure compliance with worldwide regulatory requirements a. Perform quality review of PSURs and related documents according to regulatory schedule.b. Publish PSURs and related periodic safety reports in the CREDI docbase to en-sure timely and quality delivery of the documents to Health Authorities worldwide. c. Write the summary evaluation of the medical complaints of Annual Product Re-view/Product Quality Review including corrective measures according to the schedule.3. Lead ICSR quality review initiatives to ensure accuracy and completeness of Argus data-based ICSRs in accordance with regulatory requirements a. Develop, review and maintain QC tool aimed at identifying Argus data entry er-rors;b. Review and assess the EMA Key Performance Indicator report for internal com-pliance timelines and any other specified internal compliance reports. c. Assist with the troubleshooting and correction of Individual Case Safety Reports (ICSR) processing errors / inconsistencies;d. Provide ARGUS data entry support to Global DS&E Sites and CPOs. 4. Contribute to the development and testing of safety systems/IT applications and in the preparation of relevant manuals.5. Evaluate the impact of worldwide emerging regulations on current ICSR processing pro-cedures, and drive the implementation of process changes within DS&E and across Line Functions to meet global safety reporting requirements. 6. Prepare and maintain Standard Operating Procedures and related documents for presen-tation and approval at the Process Review Committee.7. Participate in regulatory authority inspections and internal audits as ICSR expediting sub-ject matter expert. 8. Train global DS&E associates and Country Pharma Organizations (CPOs) on local ICSR tracking system, Argus safety database and Argus data entry procedures.9. Support PV Scientists with Pharmacovigilance activities e.g. review of line listings for PSURs, safety impact analyses, licensing agreements, application manual updates. 10. Work in conjunction with PV Scientists and Medical Safety Physicians (Pharmacovigilance Expert, Pharmacovigilance Leader, Brand Safety Leader) to ensure that reports are accu-rately evaluated and databased.11. Assist PV Scientists with administrative and procedural activities within specific therapeu-tic areas. 12. Deputize for the Group Head ICSR management.Minimum requirementsKey Performance Indicators (Indicate how performance for this role will be measured) 1. Number, timeliness and quality of deliverables according to established directivesJob Dimensions (Indicate key facts and figures) Number of associatesNone Financial responsibility(Budget, Cost, Sales, etc.) NoneImpact on the organization Drive the implementation of new ICSR expediting applica-tions, processes and training. Successful reporting of ICSRs to Health Authorities, Global License Partners and CPOs, both for the entire Novartis Pharma portfolio and others sectors for which Pharmacovigilance activities are delegated to Novartis Pharma, ensuring that Novartis maintains global regulatory compliance worldwide. Ensure that ICSRs from Clinical Trials and Post Marketing environment are databased in Argus accurately to meet quality regulatory requirements, Quality review and pub-lishing of periodic safety reports to comply with worldwide regulations.Ideal Background (State the preferred education and experience level) Education (minimum/desirable) Life sciences degree / Health Care Professional (nursing)Languages Fluency in English. Knowledge of other languages desirable.
Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 2-5


Clinical Research | Data Management/ Statistics | Technology Transfer Engineer
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