Pharmacovigilance / Senior Pharmacovigilance Associate
Company: ICON plc
Location: [Not specified – Global opportunities]
Job Type: Full-time
About ICON plc
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing outsourced services to pharmaceutical, biotechnology, medical device, and public health organizations.
Mission: Shape the future of clinical development and improve patient lives.
Culture: Inclusive, innovative, and collaborative.
People: Our greatest strength, driving success with passion and excellence.
Role Overview
As a Pharmacovigilance (PV) / Senior Pharmacovigilance Associate, you will support safety case processing, regulatory compliance, and risk management activities. This role is critical to ensuring accurate and timely reporting of safety events and maintaining high-quality pharmacovigilance practices.
Key Responsibilities
Case Processing & Safety Data Management
Review and process safety events (pre-marketing, post-marketing, medical devices, and drugs).
Review literature (abstracts and full articles) to identify safety information.
Generate data listings from safety databases and ensure accuracy.
Perform adverse event (AE) follow-ups (written and/or telephone).
Conduct safety review of clinical and diagnostic data.
Maintain and ensure quality of safety databases and entry guidelines.
Project & Client Support
Support development of the Safety Management Plan (SMP) and ensure consistency.
Assist in post-marketing safety activities (e.g., PSMF, RMP, PBRER).
Liaise with investigational sites, reporters, Sponsors, Medical Monitors, Project Managers, and other stakeholders.
Identify and document out-of-scope activities with PV Project Lead.
Present safety processes at kick-off and investigator meetings.
Assist with audits and inspections as required.
Reporting & Analysis
Support Aggregated Safety Reports (DSUR, IND Annual Reports, PSURs, etc.).
Support interim data analysis for DMC reviews.
Assist with SAE/AE reconciliation in line with project guidelines.
Support signal detection and risk management activities.
Ensure alignment of safety plans with client contracts.
Medical Information
Respond to and process medical information inquiries (including adverse events and product complaints) per client agreements.
What You Will Be Doing
Collecting and reviewing AE reports for compliance with regulations.
Conducting signal detection and risk assessment activities.
Collaborating with cross-functional teams to resolve safety-related inquiries.
Staying up to date with PV regulations and best practices.
Assisting in preparation of safety reports and regulatory submissions.
Qualifications
Education: Bachelor’s degree in Life Sciences, Pharmacy, or a related field (advanced degree preferred).
Experience: Prior experience in pharmacovigilance, drug safety, or related area (preferably in a clinical or pharmaceutical environment).
Skills:
Strong analytical and data management skills.
Excellent attention to detail.
Strong written and verbal communication skills.
Effective collaboration and interpersonal skills.
Commitment to quality and compliance in PV activities.
Benefits at ICON
ICON offers a comprehensive reward package focused on well-being, growth, and work-life balance.
Examples of Benefits:
Competitive salary with performance-based recognition.
Annual leave entitlements.
Health insurance options for you and your family.
Retirement planning support.
Global Employee Assistance Programme (LifeWorks) with 24/7 support.
Life assurance.
Country-specific optional benefits (e.g., childcare vouchers, gym memberships, travel passes, health assessments).
Diversity & Inclusion
ICON is an equal opportunity employer committed to inclusion and belonging.
We provide a workplace free from discrimination and harassment.
Applications are welcome regardless of race, religion, color, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
If you require a reasonable accommodation due to disability or medical condition during the application process or while performing essential job functions, please let us know.
Why Join ICON?
Be part of a global leader in clinical research.
Access continuous training and development.
Work in an inclusive and supportive environment.
Contribute to improving patient safety and saving lives.
✅ Not sure if you meet all the requirements? Apply anyway — you may be exactly what ICON is looking for!
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