Job Title: Senior Pharmacovigilance Reporting Associate
Company: ICON plc – A world-leading healthcare intelligence and clinical research organization
Work Type: Office with Flex
Employment Type: Full-time
Job Requisition ID: JR133444
Posted On: Yesterday
Locations:
India – Chennai
India – Trivandrum
India – Bangalore
About ICON
At ICON plc, we are committed to shaping the future of clinical development through innovation, excellence, and inclusivity. We strive to create an environment that fosters diversity, rewards performance, and nurtures talent.
Role Overview
As a Senior Pharmacovigilance Reporting Associate, you will play a crucial role in ensuring the accurate and timely reporting of safety data related to pharmaceutical products. You will collaborate with cross-functional teams, support compliance with global regulatory standards, and help strengthen ICON’s pharmacovigilance reporting processes.
Key Responsibilities
Prepare and submit adverse event reports and safety data in line with regulatory requirements and internal policies.
Collaborate with clinical and regulatory teams to review/analyze safety data, identify trends, and escalate potential safety signals.
Assist in the preparation of Periodic Safety Update Reports (PSURs), annual reports, and other regulatory submissions.
Monitor timelines for safety report submissions and proactively address delays/issues.
Maintain and update pharmacovigilance databases, ensuring data quality, accuracy, and integrity.
Provide training and support to junior team members on reporting procedures and regulations.
Participate in audits and inspections, ensuring compliance with pharmacovigilance reporting standards.
Stay up-to-date with evolving regulatory guidelines and industry best practices.
Qualifications & Experience
Bachelor’s degree in Life Sciences, Pharmacy, or related field (Advanced degree preferred).
Strong experience in pharmacovigilance/drug safety reporting with in-depth knowledge of global regulations and guidelines.
Demonstrated ability to prepare and submit accurate safety reports on time.
Strong analytical and problem-solving skills, with the ability to interpret safety data.
Excellent interpersonal and communication skills; effective in cross-functional teamwork.
Proficiency with pharmacovigilance databases, reporting tools, and MS Office Suite.
Ability to manage multiple projects in a fast-paced environment while maintaining accuracy and attention to detail.
High level of discretion and commitment to maintaining confidentiality of sensitive information.
What ICON Offers
ICON values its employees and invests in their well-being and growth. We offer:
Competitive salary and benefits package.
Various annual leave entitlements.
Comprehensive health insurance options for you and your family.
Competitive retirement planning programs.
Global Employee Assistance Programme (TELUS Health) with 24/7 access to 80,000+ professionals for you and your family’s well-being.
Life assurance.
Flexible country-specific benefits (e.g., childcare vouchers, bike schemes, gym discounts, travel passes, health assessments).
Culture & Inclusion
At ICON, inclusion and belonging are core to our values. We are dedicated to creating an accessible, discrimination-free workplace for all employees and candidates. We encourage applications from all qualified individuals, regardless of background.
If you require reasonable accommodation due to a medical condition or disability, please contact us during the application process.
Apply Now
If you’re passionate about pharmacovigilance and want to contribute to shaping the future of clinical development, we encourage you to apply—even if you don’t meet every requirement. You may be the perfect fit for this role or another opportunity at ICON.
👉 Are you a current ICON Employee? Please [click here] to apply.a
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