Drug Safety Associate - Adverse Event Reporting

Role Summary As aSenior 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 ensureaccurate data entry, coding, and narrative developmentin safety databases. Performcase triage, seriousness and causality assessments , and ensure case completeness according to regulatory and company standards. Review and validateMedDRA codingfor accuracy and consistency. Ensuretimely submission of Individual Case Safety Reports (ICSRs)to regulatory authorities and partners. Support preparation ofperiodic safety update reportsand reconciliation activities. Participate inaudits, compliance checks, and quality improvement initiatives . Mentor and guidejunior analystson pharmacovigilance processes and case documentation.Day-to-Day Deliverables Process and finalizeadverse event reports and safety cases . Meetregulatory timelines for ICSR submissions . Reviewcase narratives and MedDRA coding quality . Supportaudit readiness, reconciliations, and quality checks . Assist withperiodic safety report preparation . Provide guidance to junior team members onpharmacovigilance compliance and best practices .Key Skills Strong attention toaccuracy, compliance, and regulatory timelines . In-depth understanding of thesafety case lifecycle and reporting protocols . Ability to managehigh volumes of safety data with precision and urgency . Strongteam collaboration and mentoring ability . Capability toprioritize 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: Agraduate or postgraduate degree in Pharmacy, Life Sciences, or a related field . 4–6+ years of experience in pharmacovigilance or drug safety operations . Strong knowledge ofpharmacovigilance regulations, MedDRA coding, and ICSR submission processes . Hands-on experience withsafety databases such as Argus, ARISg, or Veeva Vault Safety . Familiarity withregulatory timelines, compliance standards, and audit-ready documentation practices .

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