Pharmacovigilance Services Analyst
Designation: Pharmacovigilance Services Analyst
Qualifications:Bachelor of Pharmacy/BSc. Nursing
Years of Experience:3 to 5 years
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What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Pharmacovigilance Operations involve monitoring and assessing the safety of pharmaceutical products. This includes detecting, evaluating, and preventing adverse effects or any other drug-related problems. The goal is to ensure that medications are safe for patients and to comply with regulatory requirements. These operations involve collecting and analyzing data from clinical trials, healthcare providers, and patients. Effective pharmacovigilance is crucial for protecting public health and maintaining trust in medical products. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable 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). 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. • 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. • Respond to queries from clients (including internal and external) in a timely manner. • Perform monthly or quarterly reconciliations of reports as required. • Contribute to maintenance and compliance oversight of PV processes and may contribute to preparation and internal training on adverse events reporting. • 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.
Roles and Responsibilities: • 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. • Please note that this role may require you to work in rotational shifts
Chennai
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