Satya Sahu

Accomplished Pharmacovigilance and Drug Safety Professional with 12+ years of extensive experience in end-to-end ICSR processing, literature surveillance, aggregate report quality review, regulatory compliance, and safety database management. Demonstrated expertise in EudraVigilance (EVHuman & MLM) literature monitoring, SUSAR reporting, clinical safety assessment, E2B data exchange, and quality review of Individual Case Safety Reports (ICSRs) while ensuring adherence to global pharmacovigilance regulations, GVP guidelines, SOPs, and client-specific quality standards. Proven leadership in technical training, mentoring, quality governance, and operational excellence, successfully onboarding new associates, conducting knowledge transfer sessions, driving continuous process improvements, maintaining training compliance, reviewing SOPs/Work Instructions, and enhancing overall team performance.

Strong experience collaborating with global pharmaceutical stakeholders on Drug Safety projects, supporting Roche Drug Safety Standards, representing Pharmacovigilance during internal audits and regulatory inspections, and implementing best practices to strengthen compliance, inspection readiness, and operational efficiency. Proficient in industry-leading Pharmacovigilance platforms including ArisG and LSMV, with strong capabilities in literature assessment, adverse event evaluation, data quality management, aggregate report QC, documentation governance, and cross-functional coordination to deliver high-quality, compliant drug safety operations.

Guest Faculty - Self-Employed/Education

(2025-01)

Pharmacovigilance Scientist → Process Lead - TCS - Mumbai

(2013-03 - 2025-01)

• Pharmacovigilance Case Management: Managing the end-to-end retrieval and processing of EVHuman and MLM cases from the EudraVigilance database, ensuring timely and accurate case intake for pharmacovigilance operations.
• Drug Safety SOPs & Compliance: Collaborating with Roche in developing, implementing, and continuously enhancing Drug Safety Standard Operating Procedures (SOPs), training curricula, and controlled documentation to ensure global regulatory compliance.
• Continuous Process Improvement: Driving operational excellence by identifying process gaps, implementing continuous improvement initiatives, and optimizing pharmacovigilance workflows for enhanced efficiency and quality.
• Best Practice Governance: Establishing, standardizing, and promoting Pharmacovigilance best practices across teams to improve operational consistency, compliance, and cross-functional knowledge sharing.
• Project Leadership: Supporting and leading strategic Drug Safety projects while taking ownership of assigned process improvement initiatives, ensuring timely execution and successful project delivery.
• Training & Quality Review: Mentoring and coaching new team members while conducting independent Quality Control (QC) reviews of aggregate safety reports to ensure completeness, consistency, scientific accuracy, and adherence to global regulatory standards.
• ICSR & E2B Processing: Managing Individual Case Safety Reports (ICSRs) and E2B files received through data exchange systems, including validation, triage, disposition, and accurate processing of solicited and unsolicited safety reports.
• Safety Database Management: Leveraging pharmacovigilance safety databases and standardized data entry guidelines to ensure accurate case processing, high-quality data integrity, and robust quality control.
• Clinical Safety Assessment: Performing comprehensive clinical assessments of adverse events, including seriousness determination, expectedness evaluation, labeling review, and company causality assessment in accordance with SOPs, GVP guidelines, and regulatory requirements.
• Literature Surveillance: Reviewing and evaluating literature abstracts and full-text scientific publications for case validity, ensuring accurate literature monitoring and appropriate safety database processing.
• Regulatory Inspection & Audit Support: Representing the Drug Safety function during regulatory inspections, client audits, and internal quality audits while demonstrating compliance with global pharmacovigilance regulations and quality standards.
• Safety Systems Expertise: Utilizing ArisG and LSMV safety databases to support end-to-end case processing, data quality management, regulatory reporting, and pharmacovigilance operations.
• MedDRA Management: Administering accurate MedDRA coding and terminology governance to ensure regulatory consistency, data integrity, and global compliance.
• Quality Control: Driving rigorous quality control reviews to uphold data accuracy, regulatory adherence, and operational excellence across safety deliverables.
• Issue Escalation: Proactively identifying, assessing, and escalating critical issues to relevant stakeholders, ensuring timely resolution and risk mitigation.
• ISCR Review: Conducting comprehensive ISCR reviews to validate case completeness, data quality, and compliance with pharmacovigilance standards.
• Query Management: Managing end-to-end query resolution by collaborating with cross-functional teams to ensure timely, accurate, and compliant case processing.
• Safety Compliance: Ensuring adherence to global pharmacovigilance regulations, SOPs, and quality standards while maintaining inspection readiness.
• Process Improvement: Spearheading continuous process improvement initiatives to enhance operational efficiency, quality outcomes, and regulatory compliance.

Master of Pharmacy - Pharmacology - Utkal University (2011) Bhubaneswar, India

Bachelor of Pharmacy - Pharmacy - Utkal University (2009) Bhubaneswar, India