Case Processing Associate

at  Cognizant

QUALIFICATION

• Bachelor’s or Master’s degree or PhD in Health Care Studies (Pharmacy, Medicine or Nursing)
• 1-2 years of experience in Pharmacovigilance case processing

ESSENTIAL SKILLS

• High affinity to process driven tasks
• Ability to act in an intercultural setting
• Excellent written and verbal communication including professional documentation skills in English
• Excellent ability to prioritize tasks, meet deadlines and work under changing conditions and high pressure
• Concern for training
• Team Player
• Knowledge of Clinical research and Pharmacovigilance processes

• Managing mail box
• Managing intake items
• Responsible for creation/initiation of case versions in accordance with client SOP’S’s and timelines
• Perform redaction of source documents wherever required
• Perform a duplicate check for all source documents received in intake including those source documents already classified as initial or follow up to identify if an Adverse Event Report (AER) already exists for this patient and event
• Determine if the source document is an initial case or a follow up case
• Enter/confirm the initial/latest receipt date
• Complete the minimum applicable data entry of the case in accordance with client guidelines and SOPs
• Identification of missing or discrepant information (initiate any necessary queries) to ensure the processing of a comprehensive medical occurrence
• Route the case into applicable workflow
• Perform 100% accurate data entry of individual case safety reports (ICSR) with regard to applicable source documents
• Determine seriousness of the case and perform accurate prioritization
• Identify and capture details of all relevant safety information in the source document into database that includes adverse events, suspect drugs, reporter and patient data, history, lab data, concomitant and past drug details etc.
• Create safety narrative using the appropriate safety template and ensure that the medical context and chronology of the reported safety information is maintained
• Code adverse events, diseases, indications of medications and lab data using MedDRA and drugs using the applicable company drug dictionary or WHO drug dictionary
• Entry of Company Causality on selected case types as per guidance document and training
• Request missing information/translations/clarification on any discrepancies and update the case as applicable
• Route the case into applicable workflow