Icon Plc is hiring for the role of Senior Pharmacovigilance Associate for its Pharmacovigilance department in India, Chennai; India, Trivandrum. This opportunity is suitable for experienced pharmacovigilance professionals with hands-on exposure to Clinical Trial and Post-Marketing Surveillance cases.

The company is looking for candidates who are currently based in Chennai, and immediate joiners are preferred. In this role, the selected candidate will support pharmaceutical product safety activities by managing adverse event reports, safety data review, regulatory documentation and compliance-focused pharmacovigilance processes.

Job Details

Job Description

As a Senior Pharmacovigilance Associate at ICON, the candidate will be responsible for supporting the safety and efficacy monitoring of pharmaceutical products by managing and overseeing pharmacovigilance activities. The role involves collecting, evaluating and processing adverse event reports while ensuring accurate and timely reporting in line with regulatory and company standards.

The position requires experience in ICSR processing for marketed products, Post-Marketing Surveillance and Clinical Trial cases. The candidate will also work on safety data analysis, periodic safety reports, regulatory documentation, pharmacovigilance database integrity and audit readiness.

Key Responsibilities

• Handle case processing activities for Post-Marketing Surveillance and Clinical Trial cases.
• Process ICSRs for marketed products and literature ICSRs while maintaining monitoring compliance requirements.
• Evaluate adverse event reports and ensure accurate and timely reporting as per regulatory and company standards.
• Apply knowledge of seriousness, expectedness, causality and global reporting requirements.
• Support reconciliation processes and aggregate reporting activities, including PSUR and DSUR.
• Analyze safety data, interpret findings and identify trends or potential safety concerns that may require further investigation.
• Prepare and submit periodic safety update reports and other regulatory documents in line with international compliance requirements.
• Work closely with medical and clinical teams to determine the clinical significance of reported adverse events.
• Support risk management initiatives related to pharmacovigilance activities.
• Maintain pharmacovigilance databases and ensure documentation quality and data management compliance.
• Train and mentor junior staff on pharmacovigilance procedures, regulatory requirements and industry best practices.
• Review SOPs and support audit and inspection readiness for regulatory authority inspections.
• Stay updated with changing regulations and industry developments to improve pharmacovigilance processes.

Experience

Candidates should have at least 4+ years of experience in a safety background, with hands-on experience in case processing and QC, specifically in Post-Marketing and Clinical Trial cases.

Required Profile

• 4+ years of case processing experience in Post Marketing Surveillance.
• Hands-on experience in Clinical Trial and PMS cases.
• Extensive experience in pharmacovigilance or drug safety.
• Strong understanding of relevant pharmacovigilance regulations and industry standards.
• Proven ability to manage pharmacovigilance processes, including adverse event reporting and signal detection.
• Strong analytical and critical thinking skills with the ability to interpret complex data and make informed recommendations.
• Excellent communication and interpersonal skills.
• Ability to work collaboratively across cross-functional teams.
• Proficiency in pharmacovigilance databases, data management systems and Microsoft Office Suite.
• Ability to work independently and manage multiple priorities in a fast-paced environment.
• Commitment to maintaining confidentiality and handling sensitive patient information with discretion.
• Working knowledge of SDEA and KPI/SLA basics.
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Benefits

ICON offers a total rewards package designed to support health, wellbeing and career development. Benefits may include:

• Performance related incentives
• Health and wellbeing programmes including medical, dental and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

How to Apply

Interested candidates can apply online through the official application link below.