Dinesh Mali

PV Audit/inspection

• Preform yearly risk assessment of PV business partners, local affiliate, LPVRPs and global system and accordingly design tactical and strategic audit plan
• Plan and execute audit of PV Business partner, local affiliate, LPVRPs, Global system as per audit plan from initial notification to closure.
• Support to the Strategic and Operational leadership of the GVP quality domain
• Support audits and inspections conducted by regulatory authority and PV partners in global territories in the Global time zones whenever required.
• Coordinate for between Auditor and Auditees for Agenda, pre & during audit document requests
• Ensure adequate support is provided to the auditees in preparing for audits and inspections
• Available during audit to assist with document requests as and when needed in the time zone of the audit country.
• PV QMS and Compliance Monitoring
• Monitor and ensure compliance with global PV regulations, company SOPs, Pharmacovigilance and relevant agreements.
• Maintain metrics relating to the functioning of the PV Processes such as regulatory submissions, audit reports & CAPAs, training, deviations, Regulatory intelligence, RMPs etc.
• Review and approve PV relevant change control, CAPAs, Deviations.
• Review pharmacovigilance standard operating procedures (SOPs), work instructions (WIs), audit CAPA plan, other PV relevant documents.
• Design and implement PV compliance metrics to track and report adherence to internal and external requirements and highlight key findings, risks and provide recommendations
• Support in integration, mergers, and acquisition activities by performing assessment, as applicable.

• Design PV business partner audit tactical and strategic plan.
• Perform risk periodic risk assessment of PV business partners to draft audit tactical and strategic plan.
• To perform initial qualification and requalification of service providers.
• Design and execute PV business partners, from initial notification to CAPA tracking until its closure.
• Ensuring adherence to documented company standard operating procedures (SOPs) and work instructions (WIs) for Global Medical team which includes Patient Safety and Medical Information.
• Design and execute self-inspections / internal audits for key activities of Patient Safety and supporting departments such as Artwork, Quality and Regulatory in coordination with other certified quality auditors to review the pharmacovigilance system including its quality system at regular intervals based on the risk to verify its effectiveness and introducing corrective and preventive actions.
• Review of pharmacovigilance standard operating procedures (SOPs) and work instructions (WIs) for their effectiveness before implementation.
• Participate in a monthly review of different PV processes such as Periodic Safety Update Reports, Risk Management Plans, Signal detection and Safety communication and having a compliance oversight on these processes.
• Support in compiling PSMF updates for internal audits; Open Deviations and Open CAPAs followed by the Quality Review of updated PSMF.
• Ensure compliance to Artwork implementation management following Reference Safety Information updates.
• Define and present monthly PV compliance metrics to the management.
• Support in integration, mergers, and acquisition activities by performing assessment of the ‘Pharmaceutical Quality System' with respect to GVP modules, identify risks and determine its Corrective and Preventive Actions.
• Participate in company audits and inspections by business partners or competent Regulatory Authorities.
• Maintain strong working relationships with Patient Safety and other support departments to ensure CAPA's arising from audits are logged, managed, and completed within agreed deadlines.
• Maintain strong working relationships with the Qualified Person for Pharmacovigilance (QPPV) to ensure critical non-conformances identified during audits are escalated immediately and all other non-conformances are reported in a timely manner.
• Generation and review of Standard Operating Procedures and Work Instructions relating to PVQA systems.
• Contribute towards continued improvement of PV systems and processes.

• Team Management Responsibility:
• Assigned task/priorities and monitor resources performance and provide feedback/guidance as required.
• Provide oversight and guidance on organizational goal and organizational objectives.
• Set up yearly objectives (KRA/KPI) and annual performance review and appraisal of assigned resources.
• Monitoring team performance to ensure objectives are met.
• Responsible for handling quality and compliance of team of around 30 associates, along with that responsible managing quality compliance of stake holder, business partners and service providers around the globe.
• Responsible for leave and resource management.
• Drafting and finalizing Process mapping and defining and finalizing Business Process and Business controls.
• QMS Responsibility:
• Preparation and review of SOPs/WIs/Policies/Conventions.
• Preparation, review, and maintenance of safety data exchange agreement/pharmacovigilance agreement/any other agreement, as applicable.
• Ensure timely processing and submission of ICSRs as per applicable SOPs/WIs/agreements and regulatory requirements.
• Review of Periodic Safety Update Report (PSUR)/Periodic Adverse Drug Experience Report (PADER)/Risk Management Plan (RMP)/other periodic reports and ensure their timely submission as per regulatory requirements.
• Ensure timely sharing of the reconciliation report with concerned stakeholder(s) as per applicable procedure/agreement.
• Review of all logs/trackers/forms related to pharmacovigilance activities, as applicable.
• Monitoring overall compliance of pharmacovigilance activities.
• Identify deviation(s), if any, and implement CAPA as required.
• Conduct internal audit(s)/vendor qualification audit(s)/other pharmacovigilance audit(s), as assigned.
• Handling of all queries from concerned stakeholders and/or regulatory agencies, as required.
• Maintain awareness with respect to new regulations affecting pharmacovigilance activities.
• Impart pharmacovigilance training to team members/concerned stakeholders, as applicable.
• Ensure that all pharmacovigilance-related documents are archived and handled as per the applicable procedure.

• Collaborates with Sponsor/Customer and major functional area leads (e.g., Project Management, Clinical Monitoring, SSU, Medical Writing, Data Management, etc.) as the key liaison between the client and SPVG department.
• Ensures all project deliverables meet the internal and external customers' expectations as per contracted deliverables, provide accurate projections, reports and updates, and ongoing risk assessments.
• Provides oversight of all project SPVG deliverables, which encompasses all activities throughout the duration of the project/program.
• Team Quality management and Workflow Management activity.
• Develops and maintains relationships with customers in alignment with their assigned projects. May collaborate with business leads for business development, alliance management, contracts and proposals development, project management, and clinical management to achieve project goals.
• Participates in audits/inspections and always ensures inspection readiness. Participates in quality investigations and implementation of corrective and preventative actions (CAPA).
• Developed training materials for pharmacovigilance conducts PV training and maintains training records for relevant internal and external stakeholders, where applicable.
• Communication with internal and external stakeholders regarding different medical and safety documents and site communication.
• Maintains accurate KPIs/metrics and provides to PV management /appropriate function in a timely manner.
• Managing product-related queries including medical, safety, and approval of responses to medical inquiries, by obtaining information from internal sources (e.g., safety, regulatory, development, research) and published materials.
• Answers to unsolicited requests by HCPs or internal departments using medical documents.

• Review and assess all source documents, and compile data in an adverse event report and release report to client through client safety database.
• Search the safety database for duplicate reports. Evaluate case information for Medical Completeness. Each reported adverse event within a case is evaluated for a potential upgrade for seriousness. Medical judgment is exercised in deciding whether an upgrade is appropriate and the upgrade is documented.
• Coding of adverse events, medical history, lab tests, etc. by using the MedDRA dictionary and client guidelines.
• To assess the expectedness and causality of events with respect to the suspect drug.
• Responsible for training new candidates, reviewing cases processed by them, and giving them appropriate feedback.
• Performing quality reviews of cases processed by the Medical Safety Specialist (case processing team).
• Responsible for the quality of the team and used to conduct quality meetings frequently to improve process quality.

• Evaluate ICSRs for seriousness, and expectedness and assess investigator or company-supplied causality.
• Processes Including duplicate checks, MedDRA coding, narrative writing and tracking.
• Identifies ICSRs requiring expedited reporting according to applicable requirements including both paper-based and electronic reporting.
• Evaluate ICSRs for additional information needed to order to fully evaluate the case according to the principles of good pharmacovigilance practice and ensure this additional information supplied by contact report or via CRO/CRA.
• Communication with clients, investigational sites and reporters, and other client service providers.
• Prioritization of activities to meet client and regulatory time-line. Monitor daily incoming communication (e.g., email, post, telephone, and fax) for ICSRs to report to GPE.
• Ensure that processes are in place to receive ICSRs in a timely manner from other functions/groups within the affiliate (e.g., sales representatives, medical information or any other group that has first contact with a reporter).
• Determine the necessity for follow-up and prepare follow-up request as needed.
• Work in conjunction with Clinical Safety Associates, Clinical Safety Scientists from other processing sites and Medical Safety Physicians (Pharmacovigilance Leader and Brand Safety Leader) to ensure that reports accurately evaluated and database.
• Work with external partner groups, e.g. co-licensing partners and Clinical Research Organizations to meet joint accountabilities.
• Validity assessment, triage, and processing of literature cases for databasing or passing them on to the Team Leader for approval of rejection.
• Co-author, together with the Medical Safety Physicians, all required regulatory periodic reports, collecting, organizing, and presenting the available data.

• Communication with the Sponsor and IEC.
• Preparation of Protocol and Case Report form and clinical study report.
• Reporting of AE and SAE to the Sponsor, Ethics Committee, and Regulatory agency.
• Preparation and Compilation of Pre-Study, During Study, and Post-Study Trial Master file (TMF) as per ICH GCP §8.
• Counseling and taking informed consent of the subject for screening and study.
• Communication with group leader, Hospital, Caterer, and Pathology Laboratory.
• Securitization and Submission of clinical study documents to Regulatory agencies.
• Maintaining Acceptance, Dispensing, and Accountability record of Investigational product.
• Registration and Identification of Volunteer by database system