Dr. Kirandeep Bhutta

Pharmacovigilance Scientist experience:

• Management of activities related to the processing (including triage, duplicate detection, case registration, data entry in safety database) of ICSRs in accordance with the applicable client and regulatory requirements
• Maintaining good knowledge of data entry conventions and international regulations for vaccines and drugs including:

- ICH guidelines on safety and efficacy

- New EU PV legislation and GVP modules

- FDA guidelines

• Accepting rapid notification (RN) in Argus for potentially serious cases/escalated cases and performing data entry of the case
• Performing MedDRA coding in accordance with 'MedDRA Term Selection: Points to Consider'
• Involved in training and mentoring of new team members, as needed
• Interacting with internal or external stakeholders to resolve queries or issues related to the project work
• Involved in inspection readiness activities, and providing support for audits and inspections
• Maintaining a good working knowledge of client procedures/guidelines, and safety profile of assigned products
• Requesting translation for untranslated documents, receiving the translated documents and performing reconciliation of the translation requests
• Sending partner notification for Partner cases and receiving partner assessment for potentially serious cases
• Being well versed with applicable international regulations, and global regulatory reporting obligations
• Organizing workload to ensure compliance with internal and regulatory timelines
• Performing tracking and reconciliation activities, as required
• Performing additional activities, as required.

• Performing QC/QA of ICSRs (as applicable) processed in accordance with conventions and guidelines Ensuring compliance of ICSRs with regulatory requirements.
• Maintaining quality metrics per requirements Performing trend analyses of the data, as applicable Highlighting any issues emerging from the QC/QA results to the Team Leads/Project Manager and contacts, as required.
• Performing quality review of ICSRs to ensure accuracy and completeness of data captured in the safety database, and that the ICSRs have been processed in accordance with the applicable procedures and guidelines.
• Ensuring high quality of assigned work in accordance with quality parameters.
• Providing guidance to new Quality Scientists, as applicable.
• Interacting with internal or external contacts to resolve issues related to the assigned work.
• Being well-versed with the safety profile of the assigned vaccines and drugs, ICSR processing conventions, guidelines.
• Performing activities related to submission of ICSRs to regulatory authorities and partners within timelines.