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Senior PV Associate

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

1. Lead worldwide E2B deployment in coordination with PVSDM to comply with national regulationsa. 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 activitiesc. 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 requirementsa. 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.
Degree: M.Com. (Commerce) | M.Pharm. (Pharmacy) | M.Sc. (Science) | MA (Arts) | MBA/ PGDM | MCA/ PGDCA

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: 3-8


Performance Mgmt | Recruitment | Training & Development
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