Swetha Eldi

• Performed initial evaluation of processed cases in various workflows (Triage, duplicate search,book-in and data entry) in ArisG database and routing to appropriate workflow.
• Ensure to review oversight errors in ICSR submissions.

Perform data entry of safety events into internal database,ensuring accurate entry of case information.

• Performing conduct of follow-up activities on safety cases from initial reporter, ensuring regulatory timelines.
• Manage AE/PV inbox,investigating and clarifying case details by querying the team, sending emails for resolution, and tracking updates until case completion.
• Retrieve source documents and emails from internal database, ensuring accurate access to relevant information and for audit purpose.
• As a Subject Matter Expert (SME) for special case scenarios conducting investigation for quality cases and training team on error mitigation using live case scenarios, SOPs and also weekly quizzes to assess team knowledge ans schedule one-on-one meetups to address knowledge gaps and provide targeted support.
• To perform investigation on CAPA and take necessary actions.
• Provide support with reconciliation activities as needed, ensuring program requirements are met, and data accuracy is maintained.
• Assisting in resolving discrepancies and issues that arise during the reconciliation process.
• Conducting source data verification activities as required, adhering to program requirements and PV agreements, to ensure data integrity.
• Reviewing and validation of data for accuracy, completeness, and consistency.
• Collaborating with relevant teams to manage and resolve adverse events, product quality complaints, and medical information inquiries.
• Participating in internal audits and quality assurance activities to identify areas for improvement.
• Building of excellent rapport with internal and external customers, maintaining a high level of customer satisfaction through effective communication and issue resolution.
• Providing timely and accurate responses to customer inquiries, demonstrating a customer-centric approach.
• Maintaining confidentiality of patient, client, and corporate information at all times, adhering to data privacy regulations and company policies.
• Participating in proactive Health and Safety activities, reporting any risks or concerns to the immediate Supervisor, and contributing to a safe work environment. Possess knowledge of ICH, GDP, GCP, Health Canada GVP, and Health Canada Adverse Event Reporting guidelines, with familiarity with Canada Vigilance-MedEffect Program, to ensure compliance with regulatory requirements.
• . Completing other tasks as requested or required, demonstrating flexibility and adaptability in the role, and contributing to the team's success.

• Processing all types of cases which include Spontaneous,Solicited, literature, Clinical trial, Non-Serious and NIS cases and Life threatening cases.
• Responsible for scheduling and maintenance of annual reports which include (PSUR/PEBRER/IRSR/AR).
• Assist in the preparation, review, and evaluation of signals, aggregate reports (ASR/PSUR/PBRER), Issue Related Summary Reports (IRSR), and Risk Management Plans (RMP).
• Contribute to generating responses to regulatory authority requests on product safety-related issues for marketed products or products in development.
• Performs data-entry of Individual Case Safety Reports (ICSRs) into safety databases.

Conducts assessment of ICSR seriousness, expectedness and causality.

• Performs reconciliation activities with clients and clients' partners. Ensuring quality of the PV activities (including Signal, ASR/PSUR/PBRER, and Literature monitoring) through a retrospective quality review.
• Assist in the preparation and review of safety sections of the Canadian Product Monograph (CPM) including the serious side effects table under patient medical information.
• Assist in the preparation of the Drug Safety Reports (DSR) following receipt of the OOS/OOT result on the quality/stability testing of the products or identification of foreign particles to support preparing the Health Hazard Assessment (HHA) report. Develops and maintains SOPs, Safety Data Exchange Agreements (SDEA) with business partners, and training documents and tracks compliance of internal and external global partners.
• Notifying Health Canada of Foreign Actions and serious risk of injury to health that is relevant to the safety of the drug in Canada.
• Conducts screening of Canada Vigilance adverse reaction online database. Conducts screening of worldwide and local literature. Prepares Line-Listings and Summary Tabulations for Annual Summary Reports.
• Trains on PV and/or Client Pharmacovigilance Standard Operating Procedures.

• Perform PV and MDV activities for our clients in compliance with company SOPs, working practices, and regulatory guidelines.

• Perform training of study related materials related to case processing of ICSRs for a clinical trial, including the study protocol and Safety Management Plan (SMP).

• Perform PV activities in a timely manner according to regulatory and sponsor reporting requirements.

• Perform as the Lead Safety Associate for assigned trials, ensuring compliance with all PV requirements.

• Perform quality control (QC) review of case processing by other PV personnel.

• Review hardcopy and/or electronic SAE/device incident/pregnancy report forms and supplementary reports to ensure that redaction of personal identifying information has occurred, as necessary.

• Perform QC review of data in the safety database for cases entered by other PV personnel, ensuring data accurately reflects the relevant case details in the source documents.

• Review the patient narrative, ensuring it adheres to the narrative template and accurately describes the case details and is up-to-date, complete, and concise.

• Generate queries for any critical or missing information. Send queries to the Data Manager for posting to the clinical database and/or generate Data Clarification Forms (DCFs) and send queries directly to the study sites.

• Ensure all case documentation is filed and saved appropriately, including uploading of source files into Argus.