Job Title: Senior Pharmacovigilance Reporting Associate
Location: CHN/BGLR (Office-Based)
About the Role:
ICON plc, a global leader in healthcare intelligence and clinical research, is seeking a Senior Pharmacovigilance Reporting Associate to join its dynamic team. This role offers the opportunity to drive safety reporting excellence while advancing clinical development projects that improve patient lives.
At ICON, our people are at the heart of our success, and we are proud to foster an inclusive environment. We value innovation, integrity, and collaboration, and we are looking for talented professionals to join our mission to improve drug and device development.
What You Will Be Doing:
Expedited and Periodic Safety Reporting:
Submit expedited Serious Adverse Event (SAE) reports, periodic reports, line listings, and other relevant safety information to regulatory authorities, clients, ethics committees, and other stakeholders, meeting project timelines.
Safety Reporting Intelligence:
Release safety reporting intelligence in line with company procedures and timelines, ensuring compliance with regulatory requirements.
Project Oversight and Leadership:
Oversee assigned projects, ensuring that all ICON, sponsor, and regulatory timeframes are met for safety reporting. Lead safety reporting activities, ensuring accountability and the highest standards.
Compliance and Regulatory Adherence:
Maintain a strong understanding of ICON's safety reporting systems, processes, and SOPs. Ensure all reporting activities adhere to regulations and client agreements.
Collaboration Across Teams:
Build and maintain strong relationships with project teams, investigators, vendors, and clients to ensure effective collaboration and communication across functional units.
Database Management and Quality Control:
Ensure proper maintenance of safety reporting information in various databases. Perform quality control of documents for the eTMF and other filing solutions, ensuring readiness for audits and inspections.
Audit and Inspection Support:
Prepare for and participate in audits and inspections, representing the safety reporting department as necessary.
Training and Mentorship:
Mentor and support less experienced associates, providing guidance on safety reporting activities and promoting best practices.
Client and Internal Meetings:
Represent the Safety Reporting department in client and internal meetings, providing updates on project status and ensuring alignment with project requirements.
Travel Requirements:
Occasional travel (approximately 10%) may be required, both domestic and international.
You Are:
Qualifications:
Skills:
What ICON Can Offer You:
ICON provides a competitive salary and benefits package that includes:
At ICON, we’re committed to diversity, inclusion, and creating an accessible and supportive work environment for all candidates.
Why ICON?
ICON is an equal opportunity employer, fostering a workplace free of discrimination and harassment. We encourage diverse candidates to apply and offer reasonable accommodations for individuals with disabilities to perform the essential functions of the role.
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