Dr.Prashant Sali Email & Phone Number

Pune, Mh, In

Mumbai, Maharashtra, India

Mumbai, Maharashtra, India

Mumbai, Maharashtra, India

Mumbai Area, India

 Prepare training schedule for training database cases. Tracking and checking of all the trainings related documents of the mentees. Mentoring the new associate for case initiations, case processing (initial data entry, drug coding, event coding, narrative writing and labeling) as defined in training modules, applicable SOPs and good pharmacovigilance practices. Conduct error review meeting with mentees to discuss area of improvement. Taking routine refresher training as per process requirement. Provide the training of the new updates/conventions provided by the client. Timely communication with client in case of any new project/assignment and new conventions. Demonstrate high level of proficiency towards all level of assignment. Maintain awareness of changes to new regulations affecting pharmacovigilance activities. Checking the validity of the case as per the source documents. Giving approval to delete the case if not meeting basic criteria for database the case. Review and approve whether the cases are duplicates of each other and delete the identified duplicate cases. Review and approve whether the clinical case will be deleted as per the investigator/reporter assessment/applicable guidelines or SOPs. Review of KPI on monthly basis and identify key areas of improvement and conduct of feedback sessions for the respective associates. Review of RCA and CAPA of team members for compliance cases. Giving refresher on the areas due to which cases missed compliance, to avoid error Checking of the training files and help in the preparation for incoming audits (internal or client audit) or inspections. Back up TL within the team, carrying out the activities of the team in the TL"s absence and providing technical expertise. Distribution of the cases within the team and keeping record of all unactioned items.

Mumbai

A) Quality check:  Checking the ICSR that relevant information form source documents captured in the case. Checking the appropriate MedDRA linking done, chronology of narrative, and ensure that appropriate follow up generated to obtain missed information Providing timely feedback to the case processor regarding the errors identified during QC check. Tracking the information about the error identified In ICSR and providing the required training. Preparation of quality matrices for the individual DSA and providing them monthly reports of errors.B) Drug safety associate:  Processing all types of cases as per applicable guidelines (EMEA/FDA/ICH-GCP) and SOPs. Receive information on adverse events, perform initial checks, search database to prevent duplicate entries, create case file and initialize received drug safety reports in the DS&E tracking tool and/or safety database. Ensure scientific rigor through accurate, complete and consistent data entry of adverse event reports from source documents with emphasis on timeliness and quality.  Coding of SAE/AE by using MedDRA dictitionary. Prepare narratives summarizing the essential details of the case. Labelling of an adverse events. Evaluate and finish processing of non-expeditable reports, including review for completeness and accuracy. Identify clinically relevant information missing from case report and facilitate its collection by preparing follow-up request as needed.