Are you ready to join ICON plc, a world-leading healthcare intelligence and clinical research organization? This role offers an opportunity to be part of an inclusive, innovative environment focused on shaping the future of clinical development.
About the Role
As a Pharmacovigilance Reporting Associate, you will be responsible for managing the submission and oversight of safety reports and regulatory documents to ensure compliance with applicable standards, timelines, and client requirements.
Key Responsibilities
Safety Reporting
- Submit expedited SAE reports, periodic reports, line listings, and other safety information to stakeholders, including regulatory authorities and ethics committees.
- Maintain expertise in ICON’s safety reporting systems, processes, and SOPs.
Project Oversight
- Lead and oversee safety reporting activities on assigned projects, ensuring adherence to regulatory and client standards.
- Ensure timely updates to project and intelligence databases.
Quality and Compliance
- Perform quality control checks on submitted documents for audit readiness.
- Represent the department during audits and inspections.
Collaboration and Mentorship
- Work closely with project teams, clients, investigators, and vendors.
- Mentor and coach junior associates in safety reporting activities.
Process Improvement
- Participate in routine project activities, including client meetings and budget reviews.
- Stay updated on regulatory intelligence and therapeutic areas relevant to the role.
Who You Are
Qualifications
- Relevant experience in pharmacovigilance or clinical safety.
- Strong understanding of safety reporting systems and global regulatory requirements.
Skills
- Excellent organizational and communication skills.
- Ability to work within multiple databases and manage complex projects.
Travel
- Willingness to travel domestically and internationally (approximately 10%).
What ICON Offers
ICON values its employees and provides a competitive package designed to enhance work-life balance and personal well-being. Benefits include:
- Annual leave entitlements.
- Health insurance options for you and your family.
- Retirement planning programs.
- Global Employee Assistance Programme for 24/7 support.
- Life assurance and flexible, country-specific benefits like gym memberships, travel subsidies, and more.
Diversity and Inclusion
ICON is committed to creating an inclusive workplace that embraces diversity and provides equal opportunities. The company ensures that all qualified applicants receive consideration without discrimination.
