Pratibha Jagtap

Pharmacovigilance professional with 6+ years of experience specializing in medical literature surveillance, systematic reviews, and end-to-end ICSR management. Expert in screening peer-reviewed journals, identifying safety signals, and drafting high-quality regulatory narratives. Deep understanding of global regulatory guidelines (FDA, EMA, MHRA) and safety databases.

Mentored and trained new joiners to meet quality standards. Act as a key liaison between clients and cross-functional teams to resolve complex safety queries.

Literature Reviewer Safety Expert at Tata Consultancy Services (2024-04 – Present)

• Search biomedical databases such as KDP and Embase.
• Monitor journals, conference proceedings, and published case reports.
• Review abstracts and full-text articles for adverse events and safety information.
• Differentiate reportable from non-reportable literature.
• Extract relevant patient demographics, medical history, suspect and concomitant medications, adverse events, laboratory results, treatment details, and outcomes.
• Ensure complete and accurate capture of information from publications.
• Prepare literature review summaries and maintain literature tracking logs and documentation.
• Archive articles and related records according to company procedures.
• Communicate with medical reviewers and team lead regarding complex publications.
• Perform ICSR and literature reviewed QC.
• Perform case workflow management to ensure timely case completion.
• Handle shared mailboxes and coordinate work allocation.
• Support Team Lead in compliance tracking, attendance monitoring, quality tracking, refresher sessions, and internal reporting.
• Perform User Acceptance Testing (UAT) for pharmacovigilance software and process enhancements.

Patient Safety Expert & Mentor at Tata Consultancy Services (2023-05 – 2024-03)

• Provide expert guidance on end-to-end ICSR processing.
• Review complex or medically significant safety cases.
• Resolve case-processing issues and support escalations.
• Act as the primary contact for case-processing and workflow-related queries.
• Identify data discrepancies and recommend corrective and preventive actions (CAPA).
• Monitor quality metrics, team productivity, and trends to improve case quality.
• Perform QC of random reviewed ICSRs.
• Mentor team members on case assessment, coding, and narrative writing.
• Develop and deliver refresher training sessions.
• Identify process improvements in pharmacovigilance workflows.
• Participate in SOP development, revision, and implementation.
• Support internal quality audits and regulatory inspections.

Patient Safety Specialist at Tata Consultancy Services (2021-02 – 2023-05)

• Designated as Workflow Manager to perform case workflow management to ensure timely case completion.
• Handle shared mailboxes and coordinate work allocation.
• Process adverse event reports related to drugs, vaccines, and medical devices.
• Work on regulatory gateway submissions including EMA, MHRA, FDA, and PMDA.
• Perform case quality checks and ensure compliance with pharmacovigilance guidelines.
• Support Team Lead in compliance tracking, attendance monitoring, quality tracking, and internal reporting.
• Conduct brainstorming sessions and refresher training programs.
• Mentor new team members and support knowledge transfer.
• Participate in SOP preparation, review, and process improvement initiatives.
• Perform User Acceptance Testing (UAT) for pharmacovigilance software and process enhancements.
• Support automation and efficiency initiatives within the safety team.
• Collaborate with cross-functional teams to improve operational efficiency.

Patient Safety Associate at Tata Consultancy Services (2020-08 – 2021-02)

• Processed Individual Case Safety Reports (ICSRs) from intake through data entry, coding, narrative writing, and case closure.
• Performed MedDRA coding and ensured accurate entry of adverse event information in the safety database.
• Assessed case validity, seriousness, expectedness, and causality in accordance with pharmacovigilance guidelines.
• Prepared clear and concise case narratives and incorporated follow-up information.
• Managed follow-up activities for incomplete cases and tracked responses from reporters.
• Ensured compliance with regulatory reporting timelines and company SOPs.
• Participated in team meetings and training sessions.
• Handled legal, spontaneous, and clinical trial (CT) safety cases across functional teams.

Patient Safety Administrator at Tata Consultancy Services (2019-04 – 2020-08)

• Received and logged adverse event reports from various sources.
• Performed case intake and triage.
• Coded adverse events using MedDRA and medicinal products using WHO Drug Dictionary (WHO-DD) or company-specific dictionaries.
• Ensured accurate and consistent medical coding.
• Created and assigned ICSRs in the safety database.
• Maintained accurate case records and documentation.
• Monitored case timelines to ensure regulatory compliance.
• Tracked follow-up requests for missing information.
• Coordinated with case processors, medical reviewers, and quality teams.
• Archived safety documents according to SOPs.

Master of Science (M.Sc.) in Zoology - Animal Physiology – RUIA College, Mumbai University (2017)

Post Graduate Diploma in Clinical Research & Pharmacovigilance – Institute Of Clinical Research India (ICRI) (2019)