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ICON plc
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Pharmacovigilance Reporting Associate

Pharmacovigilance Reporting Associate

ICON plc

2 - 6 years

6 - 7 Lacs

chennai bengaluru thiruvananthapuram

Posted:1 month ago| Platform:

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Skills Required

ich-gcp guidelines pv drug safety clinical data management pharmacovigilance clinical pharmacy psur case processing clinical research safety compliance pharmacology argus meddra life sciences clinical trials reporting communication skills

Work Mode

Work from Office

Job Type

Full Time

Job Description

We are currently seeking a Pharmacovigilance Reporting Associate to join our diverse and dynamic team. As a Pharmacovigilance Reporting Associate at ICON, you will be responsible for the accurate and timely preparation of safety reports related to clinical trials and post-marketing activities. You will ensure compliance with regulatory requirements and contribute to the effective management of safety data to support patient safety and regulatory compliance.

What You Will Be Doing:

Preparing and reviewing safety reports, including periodic safety updates and individual case safety reports, ensuring accuracy and compliance with regulatory standards.
Collecting and analyzing adverse event data from clinical trials and post-marketing sources to support the preparation of comprehensive safety reports.
Maintaining up-to-date knowledge of regulatory requirements and industry best practices related to pharmacovigilance reporting.
Collaborating with cross-functional teams, including clinical, regulatory, and data management, to gather necessary information and resolve any reporting issues.
Ensuring the timely submission of safety reports to regulatory authorities and sponsors, adhering to established deadlines and guidelines.

Your Profile:

Bachelor s degree in life sciences, pharmacy, or a related field.
Experience in pharmacovigilance or drug safety, with a strong understanding of safety reporting processes and regulatory requirements.
Excellent attention to detail and organizational skills, with the ability to prepare and review complex safety reports accurately.
Strong communication and collaboration skills, with experience working effectively within a multidisciplinary team.
Ability to manage multiple tasks and prioritize effectively in a fast-paced, regulated environment.

What ICON can offer you:

Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

Various annual leave entitlements
A range of health insurance offerings to suit you and your family s needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

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Pharmacovigilance Reporting Associate