ICON is recruiting for the position of Pharmacovigilance Associate in Chennai and Trivandrum, India. The role focuses on clinical trial and post-marketing safety case processing, adverse event assessment, safety database management, medical coding, and regulatory compliance.

Candidates with a bachelor’s degree in life sciences and at least two years of pharmacovigilance experience involving direct case processing can apply through the official ICON careers portal.

Job Details

Position

Pharmacovigilance Associate

The selected candidate will monitor pharmaceutical product safety by collecting, assessing, processing, and reporting adverse event information while maintaining accuracy and compliance with applicable regulatory requirements.

Responsibilities

• Collect, assess, and process adverse event reports accurately and within regulatory timelines.
• Manage the safety inbox and acknowledge case receipt.
• Perform case triage and register cases in the safety database.
• Enter case details accurately and prepare case narratives.
• Code events, drugs, and medical history using MedDRA and WHO-DD.
• Apply appropriate product labelling and perform quality control checks.
• Finalise case processing and generate queries for follow-up.
• Assess seriousness, expectedness, causality, and global reporting requirements.
• Support safety-related investigations and collaborate with cross-functional teams.
• Process literature Individual Case Safety Reports (ICSRs) and maintain compliance with monitoring requirements.
• Support reconciliation processes and aggregate reporting, including PSURs and DSURs.
• Mentor new joiners and review Standard Operating Procedures (SOPs).
• Apply working knowledge of Safety Data Exchange Agreements (SDEAs) and KPI/SLA requirements.
• Maintain knowledge of pharmacovigilance regulations, global safety guidelines, and industry standards.

Eligibility and Qualifications

Candidates applying for the ICON Pharmacovigilance Associate position must meet the following criteria:

• Bachelor’s degree in Life Sciences.
• Minimum two years of experience in a safety-related role, with direct involvement in case processing.
• Solid experience in post-marketing surveillance or clinical trial case processing.
• Strong analytical skills and attention to detail in data collection and reporting.
• Excellent communication and interpersonal skills.
• Commitment to quality standards and regulatory compliance in pharmacovigilance activities.
• Legal right to work in the country where the role is based.

Required Skills

• Pharmacovigilance case processing
• Clinical trial safety and post-marketing surveillance
• Adverse event assessment and reporting
• Safety database management and case triage
• Medical coding using MedDRA and WHO-DD
• Case narrative writing and quality control
• Seriousness, expectedness, and causality assessment
• Literature ICSR processing
• PSUR and DSUR reporting
• Reconciliation processes
• SDEA and KPI/SLA fundamentals
• SOP review and team mentoring
• Regulatory compliance and safety guidelines

Application Details

Application Link