About the job

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
- Solid 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, ARIS

📌 Drug Safety Associate (India)
🏢 vueverse.
📍 India