[Hiring] Senior Analyst – Adverse Event Reporting Officer @vueverse

Role Description

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.

• 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.

Qualifications

• 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.

Requirements

• A graduate or postgraduate degree in Pharmacy, Life Sciences, or a related field.
• 3–8 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.

Company Description