Senior Pharmacovigilance Associate (Hands-on experience in handling Clinical Trial & PMS cases)

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. Looking for candidates who are currently based in Chennai.

Immediate joiners are preferred. As a Senior Pharmacovigilance Associate at ICON, you will be instrumental in ensuring the safety and efficacy of pharmaceutical products by managing and oversee pharmacovigilance activities.

What You Will Be Doing:

We are looking for an experienced professionals who has 4+ years of case processing experience in Post Marketing Surveillance.

Experience in ICSR processing for marketed products.

Knowledge of seriousness, expectedness, causality, and global reporting.

Familiarity with reconciliation processes and aggregate reporting (PSUR/DSUR).

Ability to mentor new joiners and review SOPs.

Working knowledge of SDEA and KPI/SLA basics.

Process literature ICSRs and maintain compliance with monitoring requirements.

This role involves leading efforts to collect, evaluate, and process adverse event reports, making sure all reporting is accurate and submitted on time according to regulatory and company standards.

You will analyze safety data carefully, interpret findings, and identify trends or potential safety issues that need further investigation.

Responsibilities also include preparing and submitting detailed periodic safety update reports (PSURs)



and other regulatory documents while adhering to international compliance requirements.

You'll work closely with medical and clinical teams to determine the clinical importance of reported adverse events and support risk management initiatives.

Maintaining and ensuring the integrity of pharmacovigilance databases is essential, along with upholding documentation quality and compliance with data management protocols.

The position also entails training and mentoring junior staff in pharmacovigilance procedures, regulatory standards, and industry best practices.

Participation in audits and inspections by regulatory authorities is required, with a focus on maintaining readiness and full compliance.

Remaining up to date with changing regulations and industry advancements is vital to continually improve pharmacovigilance processes within the organization

Your Profile

At least 4+ years of experience in safety background. Hands-on experience in case processing & QC specifically in Post-Marketing/Clinical Trial cases

Extensive experience in pharmacovigilance or drug safety, with a strong understanding of relevant regulations and industry standards.

Proven ability to manage the pharmacovigilance process effectively, 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, with the ability to work collaboratively across cross-functional teams.

Proficiency in pharmacovigilance databases and data management systems, as well as 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. Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include

Competitive base salary and 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. Visit our careers site to read more about the benefits ICON offers. Inclusion and Accessibility

ICON is an equal chance employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply

📌 Senior Pharmacovigilance Associate (Chennai)
🏢 ICON
📍 Chennai