ICON plc, a global leader in healthcare intelligence and clinical research, is looking to hire Pharmacovigilance Associates and Senior PV Associates for its office in Chennai, India. This hybrid role offers an exciting opportunity to contribute to the safety and monitoring of drugs, medical devices, and clinical trials.

About ICON plc

ICON is a world-leading clinical research organization (CRO) committed to innovation and fostering a diverse, inclusive workplace. With its expertise in healthcare intelligence and clinical development, ICON collaborates with some of the largest pharmaceutical, biotech, and medical device companies worldwide.

Role Overview: Pharmacovigilance Associate (Chennai)

As a PV Associate/Sr. PV Associate, you will play a critical role in drug safety and pharmacovigilance processes, ensuring the safety of pre- and post-marketed products through case processing, literature review, and safety data management. You will collaborate with global teams and liaise with stakeholders to ensure compliance with safety regulations and company protocols.

Key Responsibilities

• Review and process safety events related to pre- and post-marketing products and medical devices.
• Perform literature searches to identify relevant safety information.
• Generate safety data listings from the database, ensuring accuracy and compliance.
• Handle adverse event follow-ups via written and telephonic communication.
• Maintain safety tracking systems and project documentation.
• Support the development of Safety Management Plans and ensure project consistency.
• Assist in creating post-marketing documents like PSMF, RMP, PBRER, and aggregate safety reports.
• Collaborate with investigational sites, medical monitors, and sponsors on safety issues.
• Participate in safety audits and inspections for assigned projects.
• Assist in signal detection and risk management activities.
• Ensure data accuracy in serious adverse event (SAE) reconciliation according to guidelines.
• Respond to medical inquiries and product complaints as per client agreements.

Candidate Profile: What ICON is Looking For

• 1+ year of experience in the pharmaceutical industry or in a pharmacovigilance role.
• Strong understanding of drug safety processes and clinical research methodologies.
• Excellent communication skills in both written and verbal English.
• Detail-oriented with effective organizational and time management abilities.
• Ability to work both independently and within cross-functional global teams.

Why Work at ICON?

ICON offers a competitive salary and a comprehensive benefits package to support work-life balance and well-being. Benefits include:

• Annual leave entitlements and flexible working options.
• Health insurance packages designed to meet your family’s needs.
• Retirement planning support to help secure your future.
• Access to Employee Assistance Programs like LifeWorks, providing 24/7 support for personal and family well-being.
• Life assurance, childcare vouchers, gym memberships, and other country-specific benefits.