ICON plc, a global leader in healthcare intelligence and clinical research, is hiring for the role of Senior Pharmacovigilance Reporting Associate across multiple India locations.
This opportunity is ideal for experienced PV professionals skilled in safety report submission, ICSR processing, and regulatory compliance, looking to advance their career with a world-renowned CRO.
If you’re passionate about improving global drug safety and ensuring compliance with regulatory authorities, this role offers a strong career path, competitive benefits, and global exposure.
🔍 Job Overview
- Role: Senior Pharmacovigilance Reporting Associate
- Company: ICON plc
- Work Type: Full-time
- Location: Chennai, Bangalore, Trivandrum (Office with Flex)
- Key Skill: Safety Report Submission Experience
🧪 Key Responsibilities
As a Senior Pharmacovigilance Reporting Associate, you will:
- Prepare and submit adverse event reports and safety data per global regulatory guidelines.
- Collaborate with clinical and regulatory teams to analyze safety trends and identify crucial safety signals.
- Support preparation of PSURs, annual safety reports, and other regulatory PV documents.
- Monitor and manage safety reporting timelines to maintain 100% compliance.
- Maintain and update PV databases with high accuracy and quality control.
- Train and mentor junior PV team members on regulatory reporting processes.
- Participate in internal and external audits and inspection readiness activities.
- Stay updated with global pharmacovigilance guidelines and industry innovations.
🎓 Qualifications
To qualify for this opportunity, you should have:
- Bachelor’s degree in Life Sciences, Pharmacy, or related discipline (Master’s preferred).
- Strong experience in pharmacovigilance safety reporting and regulatory submissions.
- High proficiency in PV databases and reporting tools.
- Excellent analytical and communication skills.
- Ability to multitask in a high-volume, fast-paced environment.
- Strong attention to detail and commitment to data integrity.
🎁 Benefits at ICON
ICON provides a competitive benefits package, including:
- Generous annual leave policies
- Comprehensive health insurance options
- Retirement planning programs
- Global Employee Assistance Program
- Life assurance coverage
- Flexible benefits such as gym memberships, travel subsidies, childcare vouchers, and more
ICON’s commitment to inclusion, accessibility, and diversity ensures an equitable workplace for all employees.
📝 How to Apply
