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.
- Positive written and verbal communication skills.
- Experience in quality review/audit is highly desirable.

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