India
Performing quality check of case against the source document and entering any data found relevant during assessment Performing quality check of coding events, indications and patient history based on MEDRA. Performing quality check of coding of suspect products as well as concomitant. Performing quality check of the narrative that was previously ammended Ensuring the labeling of events of events is accurate Generating follow up information if required Assessing the validity of case. Using applications like Argus, eCTD, GDMS etc Preparing QC forms for the cases reviewed Collating the defects captured during review Providing timely feedback to agents In addition to the QC responsibilities, as a SME act as the first point of contact for all queries. Taking feedback sessions and training for the assigned associates on the basis of their QC trends. Notifying the leads about any concerns or areas requiring additional inputs from the clients. Processing expedited cases and query cases. Analyzing trends, conducting root cause /regression analysis Documentation of weekly Feedback calls with Mentors/ Trainers.
Checking the consistency of case against the source document and entering any data found relevant during assessment, Coding adverse events, indications and patient history based on MEDRA, Coding of suspect products as well as concomitant drugs using CDD and WHO, Narrative writing for Initial and Follow up cases, Performing Labeling and listedness of events, Generating follow up information if required, Assessing the validity of case. Using applications like Argus, eCTD, GDMS etc Case processing: Processed Clinical Trial cases, Solicited Serious and Non Serious cases, Spontaneous Serious and Non Serious cases. Processed Non Assessed Licensing Partner drugs cases. Book In and Data entry and cases processing of Unstructured AEM form cases in Argus. Processed cases for 11 different Therapeutic areas. Major Teams: CV, Neurosciences, Social Medicines, Hormonal team, Urology and Sexual health, Psychiatry and Mental Health. Processed safety reports of US cases and Non US cases reported globally. Duplicate search for safety report cases in Argus. Peer Review of General and Clinical trail cases