Dr. Sagar Raut Email and Phone Number

Responsible for day-to-day work, process flows and constantly endeavouring to be able to lead the team from the frontTracking of cases sent to Cognizant on a daily basis for the projectTimely metrics capture Keep an overall check on the Medical review activities Manage relevant teams from operational standpoint Setting benchmark for the team Liaise with Operation Manager regarding team management activities Communication with client from operational perspective Resource management Quality management Operations management Ensure appropriate distribution of work among direct reports Ensuring teams performance in terms of compliance with SLAs Perform annual performance appraisals of direct reports and provide regular feedback, if applicable to the Operations Manager/ Delivery Manager (during Appraisal/ whenever asked for) Directs the organization of work within the team including duty rosters and vacations, etc. Reporting to the Operations manager/ Delivery Manager on performance, status and any escalations Responsible for motivation level and retention of manpower Ensuring the ICSR (Individual Case Safety Report) is medically relevant, complete and accurate Validation of Seriousness criteria, events captured, coding, labelling Causality assessment Writing medical assessment comment Review and finalize Narratives Provide triage support for medical judgement related queries Generating Safety physician follow up request Identifying and notifying potential signals Support issuing Investigator notification if required participating in product safety meetings as applicable Responding to medical queries raised by the case processors and QCC (Quality Control) associates and provide feedbacks Review the work done by team members Communication of Resource issues/ Resignations/ Absconder to operations manager/ Delivery Managers Leave Management Managing assessment and development of team members

Medical review of ICSRs. Signal Detection activities of marketed and non-marketed products.

• Medical review of ICSRs. • Individual case histories preparation and finalization for PSURs. • Medical inputs in preparation of Risk Management Plan (RMP). • Medical justifications for Medical Inquiries associated with or without Product Quality Complaints.• Managing PSUR calendar for US and EU regions.• Medical inputs in commencing and finalizing Signal Detection activities.• Training Peer reviewers on the conventions to be taken care of

• To lead a team in Drug safety offering Pharmacovigilance services to Clients delivering a high quality data in stipulated timelines.• Overall in-charge of day to day activities for sub-processes in Pharmacovigilance/drug safety.• Provide technical expertise to Pharmacovigilance/Drug Safety.• Direct report development in identifying training needs, address performance improvement plans.• Perform tasks/Activities as communicated by Project managers.• Documentation of all project related activities.• Assist in developing and implementation of new techniques in Pharmacovigilance/Drug Safety activities.• Develop strategies in coordination with Team leads and Project managers so as to meet quality requirements efficiently and meet timelines set by client.• Provide training in operational techniques and activities undertaken within the Pharmacovigilance/drug safety unit, Client Pharmacovigilance/ Drug Safety SOP’s and other standards, undertaking training related to a project to team members.• Ensure that projects are completed within budget constraints and as per agreed timelines.• Ensure adequate resource for the project.• Recruitment and selection of team members.• Interaction and telecons-Co-ordinate and communicate effectively with primary contacts at client teams to ensure satisfactory progress of project work and timely resolution of issues.• Ensure appropriate distribution of work among direct reports.• Providing annual performance appraisals of direct reports and provide regular feedback, if applicable to Operation Manager.• Ensure compliance to SOP’s and relevant documentation.• Assisting in developing and implementing new techniques in PV activities.• Provide training in or oversee delivery of training in: Operational techniques and activities undertaken in PV, SOP and other standards, GCP• Escalation of identified unresolved issues in a timely fashion.• Responsible for managing attrition.

Medical review:• Medical review of ICSR's including verifying the coding & labelling, reviewing narratives, company causality comment, create action items, validate and perform medical assessment of the cases.• Evaluation of SAE cases (all serious, interventional studies, pregnancies) in accordance with regulatory requirements for AE reporting.• Addition of PSUR comments to individual case safety reports to facilitate PSUR authoring.• Execution of high quality, accurate and timely SAE evaluation process with a therapeutic area and contributing to continuous improvement of PV system and processes.• Confirmation of accuracy of medical coding of all SAE and drug terms (MedDRA and WHO-DD)• Verification of SAE case evaluation within the area of responsibility for conformity with Client SOP’s and Operational manuals.• Determination of completeness of single case reports as to medical content, clarification of inconsistent information, and requisition of required additional information from Client affiliates and/or subcontractors.• Participation in the review of Client’s AE/SAE reporting compliance.