Amol Manohar Kale

Develop quality management system in line with Pharmacovigilance requirements

• Periodic review and update of SOPs from a quality perspective.
• Investigate non-conformances to identify the root cause and propose CAPA
• Perform CAPA effectiveness checks as required
• Conduct risk-based audits in various accounts
• Act as quality point of contact during various client and regulatory audits/inspections

• Handling of teams managing literature review, case processing, and aggregate reports including RMPs
• Support signal management as per schedule
• Accountable for quality across these deliverables in line with process KPIs
• Assist in various Pharmacovigilance activities as Subject Matter Expert
• Contribute in development and revision of relevant procedural documents
• Perform internal and periodic quality assessment to ensure all time audit ready
• Perform root cause assessment, development/implementation, trending, and effectiveness checks of CAPAs
• Act as point of contact for regulatory inspections and corporate and BP audits
• Anticipating resource needs and recruiting/developing talent, as required and in conjunction with stakeholders
• Contribute to business process improvement initiatives

• Provide quality oversight for various Pharmacovigilance processes for their compliance with regulatory requirements
• Perform impact analysis of Pharmacovigilance regulations and legislation on existing system
• Manage and implement quality metrics for various pharmacovigilance activities
• Responsible for planning and executing audits within pharmacovigilance and cross-functional departments
• Review and evaluate audit and inspection corrective plans
• Point of contact during regulatory inspections and third party audits

• Act as subject matter expert for the team members on ICSR processing
• Review of workload and allocation of ICSRs for processing and review to the team members
• Ensure that ICSRs are prioritized to ensure compliance to regulatory and SLA timelines
• Ensure that ICSRs are processed and reviewed as per regulatory guidelines, relevant SOPs, and operational guidance documents
• Ensure that the team members are trained on the new updates from the client
• Monitor performance of team members
• Providing updates to the team and ensure escalation of critical issues to management for timely action
• Attend weekly status update/ad-hoc calls with the client

• Review of workload and allocation of assignments to team members
• Analyze performance of the team members periodically to ensure compliance with organizational SOPs, regulatory guidelines and quality metrics
• Identify training needs for the new employee/team members to ensure quality and accuracy in activities handled
• Generate periodic performance and quality reports
• Perform due diligence activities before finalization of the vendor
• Co-ordinate with legal department for signing CDA, MSA, and SOW with the vendor
• Monitor the performance of the vendor as per SOW, KPIs, and SOPs
• Attend weekly calls with vendors and ensure timely escalation/resolution of outstanding issues
• Perform audits on vendor and clients systems to ensure compliance with Good Pharmacovigilance Practice and other regulatory requirements

• Receipt of cases and their assessment to ensure that the information is adequate to qualify the case as ICSR
• Quality review of ICSRs originating from spontaneous, literature, and clinical trial source
• Literature surveillance as per Company SOPs
• Drafting and reviewing of PADERs, RMPs, and PBRERs across therapeutic areas of Oncology, Neuroscience, and Respiratory Disorders
• Drafting of departmental SOPs and work instructions for pharmacovigilance processes like case processing, literature surveillance, and signal management
• Involved end to end activities of signal management
• Preparation and review of pharmacovigilance agreement

• Involved in drafting and reviewing of following documents across therapeutic area of Immunology, Cardiovascular and Metabolism, Neuroscience, Virology, and Oncology
• Clinical Study Report: Full Study Report, Abbreviated Report, and Synoptic for Phase I, and II, Table of studies, and Narratives
• Disseminate the knowledge gained at regular intervals with the team across the projects
• Ensuring that timelines for deliverables are met and that they comply with established performance metrics
• Ensuring timely reporting of deliverables & prompt issue escalation to the Line Manager

• Input to high-quality and timely responses to safety queries
• Ensure compliance with global and local procedural documents and local implementation of applicable policies, processes and procedures
• Enter initial and follow-up information for ICSRs into the global database, using data interpretation, coding and writing skills in accordance with the current Data Entry and Process Instructions, associated SOPs and Working Instructions
• Clarifying findings of KPI to the team members and working on measure to improve quality of the cases
• Identifying relevant and irrelevant information from the source documents
• Entering the relevant information in the template along with Coding
• Drafting of Narrative