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Role Summary

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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.

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Key Responsibilities

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- 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.

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Day-to-Day Deliverables

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- 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 .

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Key Skills

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- 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 .

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Tools & Platforms

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- 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.n

Eligibility / Ideal Background

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This role is suitable for candidates who have:

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- 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 .

Apply on Kit Job: kitjob.in/job/4aliui

📌 Drug Safety Associate - Adverse Event Reporting (Chennai)
🏢 vueverse.
📍 Chennai