Drug Safety Associate - Adverse Event Reporting

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 .