ICON plc, a world-leading healthcare intelligence and clinical research organization, is hiring PV Associate / Senior PV Associate professionals in Chennai, India. This role offers an exciting opportunity to ensure patient safety, regulatory compliance, and the highest standards of pharmacovigilance within a globally recognized CRO.
If you’re passionate about drug safety, clinical research, and pharmacovigilance, this role will allow you to make a tangible impact while developing your expertise in a collaborative environment.
Key Responsibilities
As a Pharmacovigilance Associate at ICON plc, your primary responsibilities will include:
- Collecting, reviewing, and processing adverse event reports in compliance with regulatory guidelines.
- Performing literature reviews to identify safety information for pre- and post-marketed products.
- Conducting case processing, safety data analysis, and quality checks in safety databases.
- Supporting Safety Management Plans, Risk Management Plans (RMPs), and PSMF documentation.
- Assisting in the creation of Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs).
- Performing signal detection and risk management activities to ensure proactive patient safety measures.
- Collaborating with cross-functional teams including medical monitors, safety scientists, and regulatory leads.
- Supporting audits, inspections, and SAE/AE reconciliations as per project-specific procedures.
Eligibility Criteria
Educational Qualification:
- Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related field (Master’s preferred).
Experience:
- Prior experience in pharmacovigilance, drug safety, or clinical research (1–5 years preferred).
Skills Required:
- Strong analytical and data review skills.
- Good understanding of global PV regulations (GVP, FDA, ICH).
- Excellent written and verbal communication skills.
- Attention to detail and a commitment to quality and compliance.
Why Join ICON plc?
ICON offers a supportive and inclusive environment that fosters growth, innovation, and work-life balance.
Employee Benefits Include:
- Competitive salary with performance-linked incentives.
- Comprehensive health and life insurance coverage.
- Flexible work options under “Office with Flex” policy.
- Generous paid time off and retirement savings plans.
- Employee Assistance Program (EAP) through TELUS Health.
- Access to learning and career development programs.
How to Apply
