KANCHAN MATALE

Subject Matter Expert (SME) for Literature:

· Acted as SME for literature topics, overseeing worldwide medical literature monitoring for Individual Case Safety Reports (ICSRs).

· Managed a team of five individuals, managing stakeholder relationships, vendor oversight, and process improvement initiatives.

Stakeholder Management:

· Developed Matrix-driven Key Performance Indicators (KPIs) for vendor evaluation.

· Participated in monthly calls with vendors to assess deliverables and identify process gaps for improvement.

· Ensured compliance with new GVP/ICH regulatory requirements and maintained oversight on vendor quality.

Audit and Inspection Readiness:

· Participated in multiple partner audits and regulatory inspections.

· Presented and handled document requests with analytical skills, ensuring compliance for literature-related topics.

· Contributed to audit readiness efforts, resulting in no findings for literature topics.

Local Literature Screening:

· Responsible for local literature screening processes with LSOs, resolving regulatory and literature-related queries.

· Developed a process for global oversight on local screening, coordinating with local teams for audit and inspection readiness.

Automation of Literature Process:

· Played a key role in the automation of literature tool project, bridging the gap between IT and business teams.

· Provided insights on internal processes and requirements, ensuring efficiency, accuracy, and reduced human workload/errors.

SOP Simplification Project:

· Contributed to the Global SOP simplification project during the launch of the V-safe database.

· Handled Global SOPs related to triage, case management, distribution, submission, and quality.

· Authored job aids for literature processes and oversight on Global literature service provider.

Pharmacovigilance Agreements:

· Negotiated PV agreements with various partners, ensuring alignment with company processes for literature topics.

CAPA and Deviations:

· Managed CAPAs and deviations related to literature process and suggested process improvements.

· Ensured compliance with ICH/GVP standards and timely completion of action plans.

Trainer:

· Conducted on-the-job trainings and knowledge sharing sessions.

· Performed Training Needs Identification (TNI) and Analysis (TNA) to ensure compliance and address knowledge gaps.

· Mentored new associates, tracked progress, and provided constructive feedback.

SME Responsibilities:

· Managed Literature Triage processes, addressing team queries, and delivering process updates.

· Maintained an updated list of journals, communicated updates to LSOs, and assisted with queries.

Case Processor:

· Processed various types of cases including literature reports, partner reports, Health Authority reports, solicited and spontaneous reports.

· Conducted duplicate checks, triage, data entry, and medical evaluation of adverse events.

· Distribution of serious and non-serious cases to respective health authorities based regulatory requirements (EMA, USFDA, Health Canada and MHRA etc.).

· Coded information using appropriate dictionaries (Eg: MedDRA, Company Product Dictionary, WHO-DD etc.) and performed clinical assessments.

· Wrote and updated safety case narratives and generated standard safety queries.

· Ensured compliance with regulatory timelines and maintained confidentiality of patient data.

· Interacted with global and local PV units and demonstrated knowledge of safety concepts and regulations.

• Performed signal detection for ICSRs and aggregate data for company products in accordance with SOPs
• Utilized LitTRACE tool for monitoring literature results and performed triage activities to prioritize relevant information
• Maintained adherence to Pharmacovigilance SOPs, Pharmacovigilance Agreements, and safety data exchange agreements
• Ensured completeness, accuracy, and regulatory reportability of adverse eventdata, meeting internal timelines and compliance standards
• Conducted quality control checks on entered data to ensure completeness, legibility and validity
• Provided constructive feedback to team members and maintained quality metrics to uphold data integrity.

• Conducted extensive reviews of published reports, biomedical literature, and articles to gather comprehensive background information from medical databases like Medline and Embase
• Evaluated articles for their validity as case reports, ensuring accuracy and relevance in the context of drug safety
• Responsible for the accurate and timely processing of serious adverse events sourced from various documents, emphasizing quality and compliance with regulatory standards such as EMA, USFDA, and Health Canada guidelines
• Ensured precise and consistent coding of medical history, drugs, and adverse event terms to facilitate accurate data analysis
• Written concise and informative case summaries to support drug safety reporting and meet the informational needs of pharmaceutical industry clients
• Proficiently processed spontaneous and clinical trial reports within safety databases, prioritizing completeness and accuracy to uphold data integrity.