Dr. Sneha Gawde

• Draft, compile, and review aggregate safety reports including Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Risk Management Plans (RMPs), and Annual Clinical Overview (ACO).
• Ensure scientific accuracy, consistency, and compliance with Good Pharmacovigilance Practices (GVP), International Council for Harmonisation (ICH), and Good Clinical Practice (GCP) guidelines.
• Perform data analysis and interpretation of cumulative safety information to identify emerging trends, potential risks, and benefit-risk profiles.
• Collaborate with pharmacovigilance, medical, and regulatory teams to integrate clinical and post-marketing safety data into comprehensive reports.
• Contribute to signal detection activities by incorporating findings into aggregate reports for proactive risk management.
• Maintain high-quality scientific writing standards to ensure clarity, regulatory compliance, and timely submission of aggregate safety documents.

• Led Quality Check Reviewer (QCR) operations for complete case processing workflows.
• Oversaw case allocation, productivity tracking, and billing management.
• Performed RCA and implemented CAPAs to prevent recurrence of quality deviations.
• Managed inspection readiness, documentation, and compliance oversight.
• Mentored associates for audit preparedness and independent project handling.

Operational oversight and literature screening.

• Managed pharmacovigilance case processing workflows, with a focus on ICSR identification from published literature.
• Oversaw vendors for local literature screening, and coordinated timely review and documentation of findings.
• Ensured articles were reviewed for content relevance, ordered full texts when necessary, and coordinated translation as needed.
• Conducted regular performance reviews for employees to identify areas of improvement.
• Core contributions in AHT, occupancy, proper utilisation of resources, shrinkage, and attrition.
• Maintaining, monitoring and tracking records relating to training, productivity, compliance and quality along with ensuring that their individual training records are kept up to date in line with inspection readiness.
• Participating in audits and inspections as required and ensuring team is also audit and inspection ready.
• Taking team briefs, addressing issues, and updating team with any new changes and keeping • control over the Quality Control aspect for the team

Cross-functional engagement.

• Supported client interactions and provided metrics, progress updates, and reports.
• Collaborated with safety and regulatory teams to align literature findings with case assessments and compliance protocols.

Training and Process Optimisation.

• Mentored team members in safety literature processes, ensuring high accuracy and regulatory adherence.
• Proactively identify and implement opportunities for process improvement and takes accountability for implementing the same.
• Analyzing and Providing RCA CAPA for the errors or missed timelines of the cases.
• Conducted gap analysis between existing processes and best practices within the industry.

• Expertise in end-to-end processing (including book-in, data entry, quality review) of Individual Case Safety Reports (ICSRs) of cases primarily coming from clinical trial cases (received from investigator sites and post-marketing sources) with quality standards. I have worked as a quality reviewer and was also part of the medical review and assessment (MRnA) team.
• Performing ICSR registration, i.e., duplicate check, initial triage, checking within the Global Safety Databases case priority, awareness date, closure/submission timelines, and internal and external completion/submission dates.
• Perform initial safety review of adverse events to determine seriousness, expectedness, reports causality, and overall event outcome (Triage).
• Writing narratives summarizing all relevant medical information for individual case safety reports.
• Coding of events using MedDRA and ranking of events and Labelling the event using CCDS/IB.
• Have conducted training sessions for freshers on various topics including narrative writing, coding etc
• Required to query for follow up information and review responses to queries when received and update the client safety Database as required
• Identify and notify the leads of any specific quality trends identified during the quality review of the cases.
• Managed training of new recruits: Trained resources for Drug Safety and Case Processing for handling the job role of Drug Safety Specialist.
• Experienced in processing literature cases. Review of global literature and return for translation if required. Has experience in review and validity assessment of articles, triage, duplicate searches, MedDRA coding, Query identification and tracking, adding of company comments. Literature cases includes cases from medical journals, abstracts, poster, presentations, literature summary cases and full literature articles including clinical cases (including interventional and non- interventional case studies) and spontaneous reports.
  • Reviews medical record follow up to cases in litigation in accordance with US FDA Regulations. Analyzes and extract pertinent information from medical records in accordance with legal and US FDA safety regulations. Reviews legal complaints and/or summons, and case entry into Arisg.

• Admission Screening for 11 US Hospitals for screening the Patients in emergency room if they meet the criteria for admission at various levels - (ICU, Intermediate level , Acute level , Observation Level)
• Selecting the patient chart with the highest priority in regards to the time spent in the queue.Reviewing and screening the patient chart on the basis on Medicare guidelines (Milliman and InterQual tools)

• Obtained patients histories with ability to maintain their histories and care charts and responsible for examining patients and recording clinical findings
• Handled the tasks of recording orders for surgeons & physicians - medications, allergies and pertinent laboratory work Responsible for preparing and updating medical records and charts (computerized discharge summaries)
• Performed other essential tasks (RT insertion, Foley's catheterization, drain removal, stoma application) as required under the instructions of surgeon & surgical associates, wound dressings, post op dressing.