Medaboina Pooja

Pharmacovigilance (PV) Subject Matter Expertise (SME):

• Acted as the PV SME for Life Science Databases, providing leadership and guidance on case creation, scenario planning for Validation and data migration streams.

Automation & Process Optimization:

• Spearheaded automation initiatives in case processing, enhancing business operations and improving process efficiency.

Testing & Validation, Data Migration Streams Management:

• Led validation testing efforts, ensuring business requirements were rigorously tested during system design and configuration phases to align with user and functional requirements specifications (UFRS).
• Authored Operational Qualification (OQ) and Performance Qualification Specification (PQS) scripts that are aligned with UFRS document and were accurately executed.
• Led activity-based analysis of business processes, implementing recommended improvements to optimize workflow and productivity across teams.
• Contributed to multiple Data migration projects, including migrations between Aris G to LSMV Database, Aris G to Veeva Vault Safety Database, and ComplianceWire to Veeva Vault Quality Docs.
• Managed field-to-field level testing based on direct mapping, codelist mapping, and functional mapping logics during data migrations.
• Identified and documented bugs, managed retesting efforts, and provided comprehensive reporting to stakeholders to support validation and DM stream.

Software Development Lifecycle (SDLC) & Compliance:

• Collaborated closely with the software development team to resolve bugs and ensure smooth execution of the Software Development Lifecycle (SDLC).
• Ensured compliance with FDA 21CFR Part 11 requirements, facilitating regulatory adherence throughout the project lifecycle.

Project & Stakeholder Management:

• Translated complex business requirements into user stories using Jira and eQUATe, facilitating project tracking and management.
• Managed ongoing project scope changes, identified potential crises, and developed contingency plans to minimize disruptions and ensure project success.
• Led meetings, facilitated business requirement discussions, and drove issues through to resolution, ensuring timely project delivery.

Traceability & Documentation:

• Prepared detailed Traceability Matrices to ensure alignment between business requirements, validation, and testing efforts.
• Delivered and maintained comprehensive requirement documentation, presentations, and system demos to ensure alignment between stakeholders and business objectives.

System Configuration & Administration:

• Configured Argus Safety for user account management, study configurations, and product setups (both pre and post-marketed).
• Led Veeva Vault Safety system administration, configuring users, groups, products, studies, and datasheets to optimize operational success and regulatory compliance.
• Knowledge in submission/distribution rules to Health Authorities (HA's)/Partners to ensure accurate reporting and compliance.

Customer & Cross-Functional Communication:

• Ensured the resolution of customer-raised tickets within defined timelines, adhering to Service Level Agreements (SLA), and maintaining high customer satisfaction levels.
• Coordinated cross-functional communications, ensuring smooth documentation sharing, email communications, and meeting management to support business goals.
• Supported the development and maintenance of best practices and tools, driving continuous improvement within internal processes.

Quality Review & Case Processing:

• Performed comprehensive quality review of all processed cases, prioritizing cases in Aris-G and Argus databases to ensure adherence to internal policies and procedures.
• Evaluated Adverse Event (AE) case information, determining required actions based on safety protocols, medical assessments, and regulatory guidelines.
• Conducted medical assessments of ICSRs (Individual Case Safety Reports), including determining expectedness of adverse events by referencing labelling documents (e.g., SPC, CDS, IB).
• Wrote case summaries, assessed causalities, and provided company comments when necessary.
• Re-reviewed PR cases as part of random Quality Control (QC) checks per client requirements.
  

Quality Improvement & Feedback:

• Delivered quality feedback to data entry teams to drive improvements in case processing and data integrity.
• Developed and prepared quality alerts, weekly polls, and reminders to the team on common findings and client updates.
• Conducted refresher sessions and one-on-one training for team members to address recurrent errors and quality deficiencies.
• Prepared quality review trend data on a weekly basis to monitor case processing accuracy and identify areas for improvement.
• Performed root cause analysis of internal quality data, identifying issues such as human omission, discrepancies, or decision-making errors.
  

Training & Knowledge Transfer:

• Provided ongoing training sessions to the team on client convention updates, SOPs, and regulatory changes.
• Created PowerPoint presentations, flow charts, and training materials for quick reference, focusing on recurrent errors and quality improvements.
• Trained new associates, mentoring them on project-specific SOPs, global pharmacovigilance (PV) guidelines, and client-specific updates.
• Ensured proper onboarding processes for new associates, including certification and access management.
  

Data Analysis & Reporting:

• Conducted data dip analysis of internal quality metrics to track error trends and improve operational processes.
• Prepared and presented data trends through Excel charts and reports to facilitate team understanding and drive continuous improvement.
• Reconciled invalid and duplicate cases per internal QA requirements, ensuring accuracy and compliance.
  

Backup Team Lead & Team Management:

• Acted as a backup team lead, overseeing daily productivity data, case allocation, and leave tracker updates in the absence of the team lead.
• Managed access control for new joiners, ensuring they received the necessary project-specific access to internal and external sites.
• Coordinated daily team tasks and ensured adherence to the Quality Assurance Program and Quality Control (QC) reviews.
• Performed error trend analysis and provided mentorship to team members, focusing on continuous improvement and offering refresher training as needed.
  

• Responsible for case intake, duplicate check, and registration.
• Processing of all types of cases both serious and non-serious.
• Assessing causality and expectedness of adverse events as per documents like IB, CCDS, Smpc, and USPI.
• Logical Deletions for the case: Determination of all type of cases whether case will undergo for deletion or not.
• Performing the case corrections based on the quality review feedbacks.
• Had knowledge on EV triage.
• Responsible for processing device and product technical complaint cases.

Case Intake & Registration:

• Managed book-in, case intake, duplicate check, and case registration, ensuring accurate and timely processing of incoming cases.
• Handled the splitting of cases, creating multiple cases from the same source document when necessary, ensuring each case was appropriately categorized.

Data Entry & Safety Database Management:

• Responsible for full data entry of Individual Case Safety Reports (ICSRs) into the safety database, maintaining accurate and consistent data throughout the process.
• Reviewed and evaluated Adverse Event (AE) case information, determining necessary actions and following internal policies and procedures to ensure compliance and safety.

Processing SUSAR Cases:

• Processed Suspected Unexpected Serious Adverse Reaction (SUSAR) cases in clinical studies, ensuring strict compliance with 7-Day and 15-Day regulatory timelines.

Medical Coding & Safety Narratives:

• Performed coding of medical history, adverse events, and lab tests using MedDRA, with product coding via CPD and WHO-DD.
• Wrote safety narratives and labeling for case reports, providing clear and concise summaries of clinical data.
• Experienced in writing narratives for a wide range of case scenarios, including Literature, Product Quality Complaints, Spontaneous Cases, and Clinical Trials (both serious and non-serious cases).

Clinical Trials & Regulatory Compliance:

• Managed and processed cases from a variety of sources, including spontaneous, literature, E2B, clinical trial, and regulatory authority cases (e.g., EMEA).
• Handled device cases, vaccine, and product technical complaint cases, ensuring all were processed in compliance with regulatory requirements.

Literature Review & Quality Assurance:

• Worked as a literature reviewer, conducting initial reviews and performing quality checks on articles sourced from Embase.
• Applied systematic review methods, including unbiased, non-biased searches, and applied inclusion/exclusion criteria to published articles to ensure the accuracy and relevance of safety data.