Shubham Patil

• Prepare and submit safety reports to regulatory agencies as required, submission to investigators & ethics committee including PSURs, DSURs
• Experience in working with different client and led multiple studies (5 studies) as Study Lead and Backup Lead
• Experience in Case processing (Data entry), review and Case tracking, Reporting and responding to regulatory authorities, ethics committees and Investigators requests
• Data Reconciliation of incoming adverse event reports
• Collaborate closely with Project Managers and serve as safety point of contact
• Understanding and adherence to regulatory compliance for submission of pharmaceuticals to FDA (United States), EMA (European Union), and additional regulatory bodies
• Managing pharmacovigilance process, which involved in PV Mailbox handling for different client and studies, support PV document preparation and archiving of all PV-related communications
• Compliance check for individual case reporting to the responsible authorities
• Liaise with relevant stakeholders to facilitate expedited reporting and updating of corresponding contracts with Client
• Periodic revision of PMS SOPs in accordance with Client and regulatory requirements
• Generation of quality and compliance report and proper execution of action related to KPIs, Matrix, QEs and CAPAs
• Utilizing pharmacovigilance databases and analytical tools to perform in-depth safety data analysis and generate periodic safety reports.

• Handled Updating and Maintenance of Standard
• Operating Procedures (SOP), Pharmacovigilance
• Database, Study report, Working Protocol
• Trained team on database and process training and ensured to have quality data in Argus Safety Data Base and also anticipated in internal and external audits
• Liaised with clients to get clear understanding of Project needs like project improvement plans, Study timeline, weekly project, and quality meetings
• Supported Project development activities like Roistering, Workflow management Plan, Task Distribution, Moments of meeting (MOM), performing CAPA session
• Prepared and maintained QC checklist material and Processed Clinical trial documents like ICSR EudraVigilance (EV Web), CIOMS, Electronic, Safety Data Document (E2B), NIS, IS, Study and spontaneous report, Line listing, MedWatch.
• Experience In Local Affiliate Cases (LAM)

• Performed Case Receipt and triage and Central case Processing for TA like Oncology, Specialist Medicine, Consumer Health, Cardiovascular Medicine and Women Healthcare
• Proficient with Using Medical Dictionary (MedDRA), and following client's user manual, SOPs, and regulatory timelines to ensure accuracy and patient confidentiality

• Excellent working knowledge of MedDRA and WHODRUG coding dictionaries and following User Manual, SOPs and Regulatory timelines

• Collected, evaluated and followed up for patient data for PMS
• Managed various Clinical Documents types like Interventional/Observational Studies, Spontaneous reports, Social Media cases, Case from literature reviews.