ICON plc is hiring a Safety Scientist

Job Title: Safety Scientist

Company: ICON plc

Work Mode: Remote (based in Poland, Bulgaria, or Romania)

Role Overview

The Safety Scientist will support and lead pharmacovigilance activities across clinical development programs, contributing to safety surveillance, signal detection, risk management, and aggregate safety reporting. This role involves close collaboration with cross-functional teams to ensure participant safety and compliance with global regulatory standards.

Key Responsibilities

• Conduct safety surveillance activities, including review of safety listings and interpretation of safety data.
• Support the generation of aggregate safety reports, including coordination of data collection, document queries, and collaboration with clients and safety writers.
• Maintain aggregate safety report plans and support authoring or review of safety report drafts, including sponsor-authored documents where ICON is the legal representative.
• Coordinate signal detection activities, including documentation of strategies, organization of source data, and review of interval and cumulative data.
• Generate or review signal detection, validation, and assessment reports, and coordinate internal and external signal management meetings.
• Draft or review safety sections of Investigator Brochures (IB), reference safety information, CCDS/CCSI, and local labeling.
• Review safety sections of clinical trial protocols, safety listings, and individual case safety reports (ICSRs).
• Support development of Risk Management Plans (dRMP, RMP) and Risk Evaluation and Mitigation Strategies (REMS), including data collection, document coordination, and client collaboration.
• Track risk management submissions and support implementation of risk minimization measures.
• Support literature search and review projects, including authoring search plans, defining parameters, conducting searches, and reviewing results.
• Assist in development and validation of patient safety tools and systems, and provide pharmacovigilance expertise in client meetings.
• Contribute to maintenance of pharmacovigilance documentation, including Pharmacovigilance System Master Files (PSMF) and agreements.
• Assist in tracking KPIs and compliance metrics, and support audit and regulatory inspection preparation.
• Participate in process improvement initiatives, including SOP development, template maintenance, and implementation of new systems and tools.
• Support development and delivery of pharmacovigilance training for employees, investigators, and clients.
• Maintain awareness of clinical research, safety obligations, regulatory requirements, and company or client standards across the product lifecycle.
• May serve as Local or Qualified Person for Pharmacovigilance (including deputy level) as per project needs.

Required Qualifications

• Bachelor’s degree in life sciences, pharmacy, or a related field.
• Minimum of 2 years of experience in pharmacovigilance or drug safety within the pharmaceutical or clinical research industry.
• Strong understanding of pharmacovigilance principles, regulations, and safety guidelines.
• Excellent analytical and critical thinking skills, with ability to interpret complex medical and safety data.
• Strong communication and collaboration skills, with proven ability to work effectively in cross-functional teams.
• Highly detail-oriented with the ability to manage multiple priorities in a fast-paced environment.

Preferred Qualifications

• Advanced degree preferred.
• Experience in literature surveillance, safety reporting, signal management, or risk management is advantageous.

Company Culture

ICON plc fosters an inclusive environment that drives innovation and excellence. We embrace diversity and are committed to creating a workplace where inclusion and belonging are fundamental. We are dedicated to conducting business sustainably, supporting our communities, and providing a work environment free from discrimination and harassment.

Benefits

• Generous annual leave entitlements
• Flexible health insurance options for you and your family
• Competitive retirement planning offerings
• Global Employee Assistance Programme (TELUS Health) with 24/7 access to a network of over 80,000 specialized professionals
• Life assurance coverage
• Country-specific optional benefits including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, and health assessments

Equal Employment Opportunity

ICON plc provides equal employment opportunities to all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. We are committed to a diverse and inclusive workplace.