Subject Matter Expert

Orcapod Consulting Services; Pune District, Mumbai, Bengaluru; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Orcapod Consulting Services is seeking an experienced Pharmacovigilance SME to provide subject-matter expertise, ensure PV quality and global regulatory compliance across client projects.

You will review ICSRs, perform data entry and coding, mentor teammates, and drive quality improvements while coordinating with Quality, Operations, Medical Review, and client teams.

Qualifications

• Strong knowledge of Pharmacovigilance and ICSR case processing.
• Understanding of ICSR lifecycle and PV quality requirements.
• Knowledge of MedDRA coding and drug/product coding.
• Understanding of seriousness, expectedness, causality, and listedness.
• Familiarity with global PV regulations and guidelines (ICH, GVP, FDA, EMA).
• Strong analytical and problem-solving skills.
• Excellent attention to detail.
• Good written and verbal communication skills.

Responsibilities

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

Skills

Pharmacovigilance

ICSR processing

MedDRA coding

PV regulations

Data analysis

Quality audits

Communication

Root-cause analysis

Job description

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.