Job Title:
Pharmacovigilance Reporting Associate
Job Location:
Shanghai, China
Company:
ICON Plc
Job Type:
Full-time | Regular
Posted Date:
April 12, 2025
Closing Date:
May 12, 2025
Role Overview:
As a Pharmacovigilance Reporting Associate, you will be responsible for the accurate and timely preparation and submission of safety reports for clinical and post-marketing activities. This role supports compliance with regulatory requirements and promotes patient safety through the efficient management of safety data.
Key Responsibilities:
Prepare and review safety reports, including Periodic Safety Update Reports (PSURs) and Individual Case Safety Reports (ICSRs).
Analyze adverse event data from both clinical trials and post-marketing sources.
Maintain knowledge of international pharmacovigilance regulatory requirements.
Collaborate cross-functionally with clinical, regulatory, and data management teams.
Ensure all safety reports are submitted within required timelines and guidelines.
Education & Experience:
Required: Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
Experience: Prior experience in pharmacovigilance or drug safety.
Knowledge: Understanding of safety reporting procedures and regulatory frameworks.
Skills & Competencies:
Excellent attention to detail and organizational skills.
Strong written and verbal communication skills.
Ability to work cross-functionally and handle multiple projects in a regulated environment.
Team player with solid problem-solving and analytical abilities.
What ICON Offers:
Competitive salary and benefits
Health insurance options tailored to local markets
Retirement savings and planning tools
Life assurance and global EAP (Employee Assistance Programme)
Paid annual leave and flexible work-life balance benefits
Additional country-specific perks (e.g., travel pass subsidies, gym memberships, childcare support)
Equal Opportunity Employer:
ICON is committed to diversity, equity, and inclusion. All applicants will receive equal consideration for employment without regard to race, color, religion, gender identity, sexual orientation, or disability.
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