Job Title: Pharmacovigilance Reporting Associate
Location: India, CHN/BGLR (Office-based)
About the Role:
ICON plc, a global leader in healthcare intelligence and clinical research, is seeking a Pharmacovigilance Reporting Associate to join its team. In this role, you will contribute to the timely and accurate submission of safety information, ensuring compliance with regulatory authorities, client requirements, and ICON’s high standards. This is an opportunity to be part of a mission-driven organization that helps accelerate drug and device development to improve quality of life.
What You Will Be Doing:
Expedited and Periodic Safety Reporting:
Submit expedited Serious Adverse Event (SAE) reports, periodic reports, line listings, and other applicable safety information to clients, regulatory authorities, ethics committees, investigators, third-party vendors, and ICON personnel, within agreed timelines.
Safety Reporting Intelligence:
Release safety reporting intelligence for expedited and periodic reports to regulatory bodies, ethics committees, and investigators in accordance with company procedures and timelines.
System and Process Management:
Maintain a strong understanding of ICON’s safety reporting systems, processes, and conventions. Ensure all reporting activities align with ICON Standard Operating Procedures (SOPs) and regulatory requirements.
Oversight of Reporting Activities:
Oversee assigned projects to ensure ICON, sponsor, and regulatory timelines are met for safety reporting activities. Take lead responsibility for safety reporting activities, ensuring ownership and accountability.
Collaboration and Communication:
Collaborate with project teams, clients, investigators, adverse event reporters, and third-party vendors to maintain good relationships and ensure safety reporting requirements are met.
Database and Documentation Management:
Maintain accurate and up-to-date project or pharmacovigilance intelligence information across multiple databases. Perform quality control and filing of documents submitted to the eTMF or other filing solutions, ensuring readiness for audits and inspections.
Audit and Inspection Support:
Assist in preparing for audits and inspections, representing the safety reporting department as needed.
Training and Mentorship:
Mentor less experienced associates in safety reporting activities and provide coaching as required.
Project Coordination:
Coordinate routine project activities, including client meetings, investigator meetings, responses to stakeholders, and reviews of project requirements.
Travel:
Occasional travel (approximately 10%), both domestic and international, may be required.
You Are:
Qualifications:
Skills:
What ICON Can Offer You:
ICON is committed to offering a comprehensive and competitive reward package, which includes:
Why ICON?
ICON values diversity, inclusion, and belonging, recognizing that a diverse workforce fosters innovation and helps us better serve our people, patients, and clients. We are dedicated to providing an inclusive environment where all employees are respected and supported.
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