Role Summary

As a Senior Analyst – Adverse Event Reporting Officer, you will be responsible for processing, reviewing, and ensuring regulatory compliance of adverse event (AE) reports within pharmacovigilance operations. The role involves end-to-end case processing, MedDRA coding validation, and ensuring timely submission of safety reports to regulatory authorities while maintaining high standards of data accuracy and compliance.

Key Responsibilities

Process adverse event cases received from multiple sources and ensure accurate data entry, coding, and narrative development in safety databases.
Perform case triage, seriousness and causality assessments, and ensure case completeness according to regulatory and company standards.
Review and validate MedDRA coding for accuracy and consistency.
Ensure timely submission of Individual Case Safety Reports (ICSRs) to regulatory authorities and partners.
Support preparation of periodic safety update reports and reconciliation activities.
Participate in audits, compliance checks, and quality improvement initiatives.
Mentor and guide junior analysts on pharmacovigilance processes and case documentation.

Day-to-Day Deliverables

Process and finalize adverse event reports and safety cases.
Meet regulatory timelines for ICSR submissions.
Review case narratives and MedDRA coding quality.
Support audit readiness, reconciliations, and quality checks.
Assist with periodic safety report preparation.
Provide guidance to junior team members on pharmacovigilance compliance and best practices.

Key Skills

Strong attention to accuracy, compliance, and regulatory timelines.
In-depth understanding of the safety case lifecycle and reporting protocols.
Ability to manage high volumes of safety data with precision and urgency.
Strong team collaboration and mentoring ability.
Capability to prioritize workload and meet tight regulatory deadlines.

Tools & Platforms

Safety Databases: Argus, ARISg, Veeva Vault Safety
Coding Tools: MedDRA Browser
Productivity Tools: Microsoft Excel

Preferred Certifications: Advanced Pharmacovigilance, GVP/GCP Compliance Training, MedDRA Coding Certification.

Eligibility / Ideal Background

This role is suitable for candidates who have:

A graduate or postgraduate degree in Pharmacy, Life Sciences, or a related field.
4–6+ years of experience in pharmacovigilance or drug safety operations.
Strong knowledge of pharmacovigilance regulations, MedDRA coding, and ICSR submission processes.
Hands-on experience with safety databases such as Argus, ARISg, or Veeva Vault Safety.
Familiarity with regulatory timelines, compliance standards, and audit-ready documentation practices.