फार्मास्युटिकल केमिस्ट

Responsibilities/Authorities

· 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.

· 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

• इस फुल टाइम लैब टेक्निशन / फार्मासिस्ट Job में फ्रेशर वाले उम्मीदवारों की जरुरत है।