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? • Prioritise, book in, triage, and case processing activities for ICSRs in accordance with Client Guidelines, Regulatory due date, and TAT SLAs and KPIs. The case processing activity includes end to end case processing as per the agreed client requirement and case processing guidelines. • Prioritize the cases from Intake workflow, mails and other sources to create cases in global safety database, identify, review for validity of cases and move the cases to respective workflow step based on case type as per the defined timelines. • To perform collection, evaluation, and submission of Adverse Event (AE) reports, transmission, and reconciliation of pharmacovigilance data of individual case reports. This includes but is not limited TMF (Trial Master File) review download of AE reports from EVWEB and the MHRA portal and the importing of AE reports on the pharmacovigilance database. • Review the source documents (SD) for validity of ICSR, perform duplicate check in the intake workflow/safety database and confirm whether the information is medically significant or relevant and takes necessary actions in accordance with Client SOPs. • Request for missing minimum safety Information or clarification of erroneous data if needed and sent queries in accordance with Client SOP, guidelines from the Marketing company (MC) or reporter as applicable. • Complete the case processing of safety information, including but not limited to coding of relevant medical history, suspect drug, adverse event and draft narrative into the applicable Global Safety Database from the available source documents. • Assess adverse events for seriousness, causality as per applicable Client SOPs, consulting the medical reviewer or medical validator whenever needed. • Perform medical coding/Drug Coding for each ICSR in accordance with Client Guidelines and SOPs using MedDRA and WHODD.
What are we looking for? Educational and Experience Requirements: • Bachelor’s Degree in Life Sciences • 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. • Consistent demonstration of company values/behaviors. • Adverse events are evaluated accurately, and cases are processed within the required timeframes to meet regulatory requirements. • Process cases with good quality metrics. • Performs all work in accordance with all established regulatory and compliance and safety requirements.
Roles and Responsibilities: • Complete and review the evaluation of the case including reporter/company causality, prepare the narrative section and E2B sender’s comment field as per Client SOP. • Processing all the AEs, SAEs and SUSARs in the Global Safety Database according to the applicable company policies and Standard Operating Procedures (SOPs). • Other essential duties include drafting pharmacovigilance agendas and meeting minutes; accurately archiving pharmacovigilance documents; reviewing safety case data and other pharmacovigilance documents for completeness and accuracy. • Assisting with tracking, submitting and distributing of reports; assisting liaisons with the partners and cross-functional team members to ensure compliance; supporting various ad-hoc deliverables or pharmacovigilance projects; and participating in audits and inspections. • Validate data consistency and make any corrections as needed. • 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. • Perform submissions in global safety database for all the AEs, SAEs and SUSAR cases as per Client SOP, to Monitor submission related client reports and trouble shoot submission issues if any. • Perform translations of source document, case narrative, adverse events as applicable. • Monitoring, tracking and reconciliation of client mailboxes and other sources as applicable. • To perform paper and electronic unblinding process if required as per Client SOP. • Review responses to queries when received and add any follow-up information to the case narrative and other fields as required. • 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. • Archive all communications/clarifications related to the Case in the Global Safety Database. • Escalate issues or tasks outside the normal scope of work to the respective lead. If team lead is unavailable, escalate to service delivery lead/operations lead. • Please note that this role may require you to work in rotational shifts
Chennai
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