Dr. Kaveri Patil

Review of Signal reports: Responsible for Signal management activities such as signal detection, prioritization, validation, and assessment/analysis. Preparation of Signal assessment reports. Reviewing literature & writing company comment for the relevant articles. Preparation of signal evaluation reports.
Review of Aggregate reports: review of Aggregate reports including PDER, PBRER and Risk Management Plans. Provide medical expertise and training to team in the review and analysis of cases and aggregate safety information
Medical Evaluations of ICSRs: Lead medical assessment of SAE reports, including case narrative accuracy, MedDRA coding, medically relevant queries, expectedness, and causality.
Leadership: supervisory leadership and performance management to PV medical reviewers. Work collaboratively with internal EVERSANA groups in handling multiple complex tasks against regulatory and business timelines and provide teams with insight and leadership Setting clear direction, effective plans and measurable outcomes. Ensuring work is accomplished effectively by managing employee performance, work processes and other resources. Engaging employees to maximize their discretionary effort. Developing a pipeline of excellent talent to fill future business needs. Active support in root cause analysis and CAPA management, PV systems. Ensuring work is accomplished effectively by managing employee performance, work processes and other resources. Engaging employees to maximize their discretionary effort. Developing a pipeline of excellent talent to fill future business needs. Plans, organizes and coordinates various projects, programs and services.

Responsible for documenting, coordinating, reviewing regulatory documents such as periodic reports. Eg. Annual/Semi-Annual safety reports/ development safety update report, periodic safety update report, addendum to clinical overview.
Responsible for safety surveillance activities such as signal detection, prioritization, validation and assessment/analysis, as well as review, preparation, and or response to health authority’s questions. Presentation at safety governance board meetings for signal adjudication and risk categorization.
To develop and maintain safety signal detection strategy for assigned products
To prepare signal evaluation report including assessment of company safety database, literature review, clinical and non-clinical data
Prioritization and assessment of signal.
To notify client-side surveillance team of any safety signal that has been detected which may require urgent evaluation and action
To review FAERS, Vigibase and EVDAS data for signal assessment.
Facilitated preparation of and medical review of health authority responses and health hazard evaluation.
Performing risk characterization based on the risks (important and potential) identified in the Risk Management Plan (RMP).
Presenting and finalizing the important topics based on Health Authority recommendations.
Communication and representation of PV data evaluation, interpretation, and summary or conclusion as relevant.
Addressing the concerns raised by regulatory authorities and Health Authority responses.
Conducting safety review meetings as per the client requirements.
Proactively cascade new learnings and ensuring compliance to conventions and standard working practices.
To lead and manage the team activities of safety team including aggregate reporting and signal management physicians.
Identify and resolve issues, co-ordinate with client therapeutic teams, and within functional team management as appropriate.
High level proficiency of all workflow tasks
Follow up on reconciliation discrepancies.
Mentor and guide the activities of junior medical reviewers
To work as subject matter expert

AS a Global Safety Officer, responsibility included providing pharmacovigiliance expertise for assigned products and understanding of international safety regulations and guidelines.
Responsible for safety surveillance activities such as signal detection, prioritization, validation and assessment/analysis, as well as review, preparation, and or response to health authorities questions. Presentation at safety governance board meetings for signal adjudication and risk categorization.
Responsible for documenting, coordinating, reviewing and validating regulatory documents such as periodic reports. Eg. Annual/Semi-Annual safety reports/ development safety update report, periodic safety update report, addendum to clinical overview, Health Hazard Evaluation, Manufacturing lot review
Review of study protocol, IB, CSR for contributing Semi-Annual safety reports.
Performing risk characterization based on the risks (important and potential) identified in the Risk Management Plan (RMP).
Presenting and finalizing the important topics based on Health Authority recommendations.
Communication and representation of PV data evaluation, interpretation, and summary or conclusion as relevant.
Addressing the concerns raised by regulatory authorities and Health Authority responses.
Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas.
Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate.
Proactively cascade new learnings and ensuring compliance to conventions and standard working practices.

Authoring aggregate reports (PSUR/ PBRER) including standard and safety sections. Presenting relevant literature articles based on the articles retrieved from the literature databases.
Performing risk characterization based on the risks (important and potential) identified in the Risk Management Plan (RMP).
Presenting and finalizing the important topics based on Health Authority recommendations.
Performing aggregate review and giving detailed comments on safety topics and other safety physician related activities for PSUR/ PBRER.
Addressing the concerns raised by regulatory authorities.
Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas.
Communicate and interact effectively within and across all clients therapeutic teams, and within functional team management as appropriate.
Proactively cascade new learnings and ensuring compliance to conventions and standard working practices.

Participate in routine safety surveillance activities including identification of safety signals from cumulative safety data and conduct initial evaluation of those signals and document outcome
To review individual case safety reports and aggregate reports
To prepare, summarize, evaluate and document routine Safety Evaluation Review Meeting safety outputs
Literature surveillance: scientific review, assessment and summarize literature articles.
To conduct further detailed evaluation of identified signals.
To participate in routine and ad-hoc team and project related meetings like Handover Meeting, Surveillance Meeting, and Safety Management Team Meeting.
To ensure compliance with global and local procedural documents.
To maintain up to date knowledge of the products assigned with focus on the safety perspective including pharmacology, indications, safety and efficacy aspects
To participate in conducting gap analysis and identify the remedial actions for the improvement of quality of deliverables as and when required.
To provide regular work updates to lead-safety surveillance.

Provide medical expertise & judgement throughout the case-handling process with medical review of individual cases
Ensure compliance with global & local procedural documents
Maintain knowledge of products assigned
Take responsibility for appropriate capturing and coding off adverse events from the source
Medical review of individual case safety reports
Literature surveillance: Screening, scientific review and assessment.
Help in constructing medically sound narratives
Served as point of contact for queries/medical issues for case processing team regarding coding of events and understanding of cases.
Maintain communication with the Global Safety Physician
Causality assessment of drug -event pair

Curative care
Preventive and Promotive care
Reproductive and Child Health Programme
Outpatient and Inpatient care and evaluation
Immunization programmes
Minor Surgical Procedures
National Health Programmes
Training