Pharmacovigilance Services Analyst

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance
Designation: Pharmacovigilance Services Analyst
Qualifications:Bachelor of Pharmacy/Master of Pharmacy/B H M S
Years of Experience:3 to 5 years
About Accenture
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What would you do? Responsible for the review, evaluation and quality check (QC) of individual case safety report (ICSR) in global safety database and maintaining high standard of accuracy, in compliance with client standard operating procedures and global regulatory requirements.
What are we looking for? Educational and Experience Requirements: • Bachelor’s Degree in Life Sciences. 6 months to 1+ year of relevant experience in PV • Technology skills: experience with MS office, knowledge of safety database • Good knowledge of medical terminology including knowledge of applicable dictionaries like MedDRA and WHO-Drug preferred. • Good medical writing skills • Good Communication Skills • Strong English Language proficiency (Reading, Writing, Listening and Speaking). • Review and perform the case correction, case deletions of the relevant cases as per SOPs and the guidance provided by the Client within the applicable timeline. • Escalate issues or tasks outside the normal scope of work to the respective lead. If team lead is unavailable, escalate to service delivery lead. • Open to get trained and moved across roles based on business requirement. • Successfully complete and clear all applicable trainings within required timelines. • To perform assist and contribute in transition related activities as per the client requirement. Key performance indicators: • Ability to learn quickly and contribute to process improvement initiatives in consultation with management. • Consistent demonstration of company values/behaviors. • ICSRs are evaluated accurately and reviewed within the required timeframes to meet regulatory requirements. • Performs all work in accordance with all established regulatory and compliance and safety requirements
Roles and Responsibilities: •Responsibilities/Authorities • Prioritise quality review for Individual case safety report (ICSRs) in accordance with Client Guidelines, Regulatory due date and turn around time (TAT) service level agreement (SLAs) and key performance indicator (KPIs).• Evaluation and review of ICSR to ensure accurate and consistent data entry and processing from source documents, with emphasis on timelines and quality. • Assess and update adverse events for seriousness, causality, expectedness as per Client SOPs, consulting the medical reviewer or Medical Validator whenever needed.• Review the case processing of safety information, including but not limited to relevant medical history and laboratory data and therapy dates into the applicable Global Safety Database from the available source documents.• Validate data consistency and update the database fields for any changes as needed in accordance with Client SOPs• Review and update the seriousness of all the events identified based on the Client guidance document.• Perform the data entry, case processing of the ICSR in quality review step if required or route the case back to case processing step as per Client Guidelines and SOPs• Determine if any additional information is needed for clarification, or if any follow-up is necessary, and take all relevant steps to obtain any additional/missing information as stated in the relevant Client SOP.• Check for any pending action items, follow-up, clarification, corrections and ensures resolution and close the action items for the case.• Identify the errors made in the case processing step and document the same in the Inline QC checklist/tool as per applicable SOP.• Capture relevant comments, Root Cause Analysis (RCA) and update other required fields as per the Client SOP.• Request for clarification if needed and sent queries in accordance with Client SOP, guidelines from the Marketing Company (MC) or client stake holder as applicable.• Archival of all source documents, clarifications, communications and reports in the core Global Safety database for the respective ICSR.• Contribute in generating responses to regulatory authority requests on product safety related issues for marketed products or product in development