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.
Valuable 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.
Solid analytical and problem-solving skills.
Excellent attention to detail.
Positive written and verbal communication skills.
Experience in quality review/audit is highly desirable.

📌 Subject Matter Expert Pune (India)
🏢 Orcapod Consulting Services
📍 India