Begin your drug safety career! ICON seeks a Pharmacovigilance Associate to manage adverse event reporting & ensure patient safety. Life sciences degree required. Training provided. Apply today.
Launch Your Career in Patient Safety
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, and medical device organizations.
We are seeking a detail-oriented Pharmacovigilance (PV) Associate to join our global Drug Safety team. In this vital role, you will be on the front line of patient safety, ensuring the accurate and timely processing of adverse event data that protects public health and informs medical science. This is an excellent opportunity to build a foundational career in pharmacovigilance with a global industry leader, with comprehensive training and a clear growth path.
Your Mission: The Guardian of Data Integrity in Drug Safety
As a Pharmacovigilance Associate at ICON, you will be responsible for the meticulous collection, assessment, and reporting of individual case safety reports (ICSRs). Your work ensures compliance with global regulatory requirements and upholds our unwavering commitment to patient safety.
Key Responsibilities
1. Case Processing & Adverse Event Management
- Perform intake, triage, duplicate checks, and data entry of adverse event reports from clinical trials and post-marketing sources into safety databases.
- Review and verify case information for completeness, accuracy, and regulatory reportability.
- Draft narratives and code adverse events and medications using standard medical dictionaries (MedDRA, WHO-DD).
2. Regulatory Compliance & Reporting
- Assist in the timely preparation and submission of safety reports to regulatory authorities, ethics committees, and clients according to global timelines (e.g., 7/15-day reports).
- Help maintain audit-ready case files and documentation in compliance with ICH-GCP, FDA, EMA, and other global PV regulations.
- Support the maintenance of the Pharmacovigilance System Master File (PSMF) as needed.
3. Collaboration & Quality Control
- Collaborate with cross-functional teams, including Clinical Operations, Data Management, and Medical Affairs, to resolve queries and ensure data consistency.
- Participate in quality control (QC) checks of cases processed by peers.
- Contribute to departmental process improvement and standardization initiatives.
Who You Are: The Ideal Candidate
You are a meticulous, process-oriented individual with a passion for healthcare and patient safety. You have a strong foundational knowledge of medical terminology and thrive in a structured, compliance-driven environment where accuracy is paramount.
Your Required Foundation:
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a closely related field.
- 0-3 years of experience in pharmacovigilance, drug safety, clinical research, or a relevant healthcare/regulatory setting. Recent graduates with a strong academic record are encouraged to apply.
- Exceptional attention to detail and strong analytical skills for data review and interpretation.
- Excellent written and verbal communication skills.
- Basic understanding of medical terminology and a strong desire to learn pharmacovigilance principles.
- A commitment to quality, integrity, and adherence to standard operating procedures (SOPs).
What Will Make You Stand Out (Preferred):
- Familiarity with global pharmacovigilance regulations (ICH E2D, FDA CFR, EU GVP).
- Exposure to safety databases (e.g., ARISg, Argus, Veeva Safety) and medical coding dictionaries (MedDRA).
- Previous experience in a CRO, pharmaceutical company, or healthcare setting.
- Advanced degree (MSc, PharmD) in a relevant discipline.
Why Start Your PV Career at ICON?
1. Foundational Training & Growth
- Receive comprehensive, structured training in global pharmacovigilance processes, regulations, and systems.
- This role is a recognized stepping stone to senior PV specialist, scientist, and management positions.
- Gain hands-on experience with a wide variety of therapeutic areas and client portfolios.
2. Purpose-Driven Work
- See the direct impact of your work on global patient safety and public health.
- Be part of a mission-critical team that is essential to every drug development program.
3. Supportive Environment & Benefits
- Competitive entry-level salary and benefits package.
- Generous annual leave entitlements.
- Comprehensive health insurance and wellness programs.
- Competitive retirement planning offerings.
- Global Employee Assistance Programme for 24/7 support.
- Clear performance metrics and career development guidance.
Join a Culture Dedicated to Safety and Inclusion
At ICON, we believe that a diverse team is key to safeguarding patient health globally. We are dedicated to providing an inclusive, accessible environment and encourage all qualified candidates to apply.
Ready to become a key defender of patient safety?
If you have a passion for science and a keen eye for detail, we want to hear from you. Apply now to start your journey as a Pharmacovigilance Associate.
