Subject Matter Expert

We are looking for an experienced Pharmacovigilance SME to provide subject-matter expertise, perform quality checks, support case processing activities, and ensure compliance with global PV regulations and client-specific requirements.

Key Responsibilities

• Review and perform quality checks of Individual Case Safety Reports (ICSRs).
• Ensure accurate case processing, including data entry, coding, narrative writing, assessment, and follow-up.
• Review cases for compliance with SOPs, work instructions, and regulatory requirements.
• Identify errors and provide appropriate feedback to case processors.
• Act as the Subject Matter Expert for complex PV-related queries.
• Support case triage, duplicate assessment, seriousness assessment, expectedness, and causality review.
• Perform quality audits and identify recurring errors/trends.
• Conduct root-cause analysis and recommend corrective/preventive actions.
• Participate in quality calibration sessions and process improvement initiatives.
• Support training and mentoring of new and existing team members.
• Ensure compliance with applicable global PV regulations and client requirements.
• Prepare and maintain quality reports, trackers, and performance metrics.
• Coordinate with Quality, Operations, Medical Review, and client teams.

Required Skills

• Strong knowledge of Pharmacovigilance and ICSR case processing.
• Good understanding of ICSR lifecycle and PV quality requirements.
• Knowledge of MedDRA coding and drug/product coding.
• Understanding of seriousness, expectedness, causality, and listedness.
• Knowledge of global PV regulations and guidelines such as ICH, GVP, FDA, and EMA.
• Strong analytical and problem-solving skills.
• Excellent attention to detail.
• Good written and verbal communication skills.
• Experience in quality review/audit is highly desirable.