Job Title: Pharmacovigilance Reporting Associate
Location: Remote
Department: Pharmacovigilance
About ICON:
ICON plc is a leading global healthcare intelligence and clinical research organization that drives innovation and excellence in clinical development. We aim to shape the future of clinical research and are committed to fostering an inclusive, diverse environment where all employees can thrive. Join us in our mission to improve the lives of patients through innovative research and clinical development solutions.
Role Overview:
The Pharmacovigilance Reporting Associate is responsible for the submission of Serious Adverse Event (SAE) reports, periodic reports, line listings, and other safety-related information to clients, regulatory authorities, ethics committees, investigators, and other third-party vendors, ensuring compliance with ICON’s procedures and regulatory requirements. This position requires strong knowledge of pharmacovigilance reporting processes and regulations, the ability to work across multiple databases, and the capacity to collaborate effectively across teams.
Key Responsibilities:
Safety Reporting:
Submit expedited SAE reports, periodic reports, and line listings to clients, regulatory authorities, and investigators within specified timelines.
Release safety reporting intelligence (expedited and periodic reports) for regulatory authorities and ethics committees in compliance with ICON and sponsor requirements.
Oversight & Compliance:
Maintain oversight of assigned projects to ensure compliance with ICON, sponsor, and regulatory timelines.
Ensure accurate completion of project activities in accordance with ICON standards, regulatory requirements, and client obligations.
Collaboration & Relationship Management:
Collaborate with project team members, client contacts, investigators, and third-party vendors to maintain strong relationships and ensure smooth operations.
Support safety reporting group management in quality and compliance reviews, finance tracking, and resource oversight.
Data Management & Reporting:
Work within multiple databases to maintain project or pharmacovigilance intelligence information.
Perform quality control of documents and ensure readiness for audits or inspections.
Mentorship & Training:
Coach and mentor less experienced associates in safety reporting activities.
Client & Investigator Engagement:
Represent the department at client and investigator meetings and ensure timely responses to all inquiries.
Audit & Inspection Readiness:
Prepare for and participate in audits and inspections, ensuring that all relevant documents and files are properly maintained.
Continual Learning & Regulatory Updates:
Stay updated on current regulations and safety reporting practices to ensure compliance and quality in reporting.
Qualifications:
Education:
Bachelor’s degree or equivalent in life sciences or a related field.
Experience:
Experience in pharmacovigilance, clinical research, or related fields is preferred.
Strong understanding of ICON safety reporting systems, SOPs, and regulatory requirements.
Skills:
Excellent organizational, time-management, and multitasking abilities.
Strong verbal and written communication skills, with the ability to liaise effectively with clients and internal teams.
Ability to work across multiple databases and manage large volumes of data.
What ICON Offers You:
Competitive Salary & Benefits:
Health insurance, retirement planning, life assurance, and other comprehensive benefits tailored to your needs.
Work-Life Balance:
Flexible leave entitlements and a range of optional benefits such as childcare vouchers, discounted gym memberships, and health assessments.
Employee Assistance Program:
Access to a global network of over 80,000 professionals to support your well-being.
Diversity & Inclusion:
A culture that celebrates diversity and fosters inclusion, ensuring equal opportunities for all employees.
Travel Requirements:
Up to 10% travel, domestic and international, as required.
ICON is an Equal Opportunity Employer.
We encourage applicants from all backgrounds and experiences to apply. We are committed to providing an inclusive and accessible environment and ensuring all candidates receive equal consideration for employment.
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