Safety Scientist
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
Safety Scientist (Remote – Poland, Bulgaria or Romania)
We are currently seeking a Safety Scientist to join our diverse and dynamic team at ICON. In this role, you will contribute to the delivery of specialized pharmacovigilance services, supporting safety surveillance and risk management activities across clinical development programs. You will work with cross-functional teams to review and interpret safety data, ensuring the protection of clinical trial participants while supporting the development of innovative treatments and therapies.
This is a remote role and can be based in Poland, Bulgaria, or Romania.
What you will be doing
You will support and lead pharmacovigilance activities across assigned projects, including safety surveillance, signal detection, risk management, and aggregate safety reporting. Working under the guidance of a Director, Pharmacovigilance Specialized Services and/or a Senior Principal or Principal Safety Scientist, you will contribute to the scientific oversight and operational delivery of safety activities.
Key responsibilities include:
Conducting safety surveillance activities for assigned projects, including reviewing safety listings and interpreting safety data.
Supporting the generation of aggregate safety reports, including coordinating data collection, document queries, internal and external reviews, and collaboration with clients and safety writers.
Maintaining aggregate safety report plans and supporting the authoring or review of safety report drafts, including sponsor-authored drafts where ICON is the legal representative.
Coordinating signal detection activities, including documenting signal detection strategies, organizing source safety data, and reviewing interval and cumulative data in accordance with safety surveillance plans.
Generating or reviewing signal detection, signal validation, and signal assessment reports, and coordinating internal and external signal management meetings.
Drafting or reviewing safety sections of product reference documents including Investigator Brochures (IB), reference safety information, CCDS/CCSI, and local labeling.
Reviewing safety sections of clinical trial protocols, safety listings, and individual case safety reports (ICSRs).
Supporting the generation of development Risk Management Plans (dRMP), Risk Management Plans (RMP), and Risk Evaluation and Mitigation Strategies (REMS), including coordinating document preparation, collecting and reviewing data, and working with clients and internal teams.
Tracking risk management submissions and supporting the implementation and communication of risk minimization measures.
Supporting literature search and review projects, including authoring literature search plans, defining search parameters, conducting literature searches, and reviewing literature in accordance with project-specific plans.
Supporting the development and validation of patient safety tools and systems and assisting project teams in client meetings where pharmacovigilance expertise is required.
Contributing to the maintenance of pharmacovigilance documentation, including Pharmacovigilance System Master Files (PSMF) and pharmacovigilance agreements.
Assisting with the maintenance of key performance indicators (KPIs) and compliance metrics, and supporting preparation for audits and regulatory inspections.
Participating in process improvement initiatives including development and maintenance of SOPs, work practices, templates, and best practices, as well as supporting implementation of new systems, databases, and tools.
Supporting the development and delivery of pharmacovigilance training for ICON employees, investigators, and clients.
Maintaining awareness of clinical research development, safety and risk management obligations across the product lifecycle, regulatory requirements, and ICON or client standards.
Depending on project needs, you may also serve as a Local or Qualified Person for Pharmacovigilance (including deputy level) in accordance with the project-specific plan.
Your profile
Bachelor’s degree in life sciences, pharmacy, or a related field; an advanced degree is preferred.
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 the ability to interpret complex medical and safety data.
Strong communication and collaboration skills, with the ability to work effectively with cross-functional teams.
Highly detail-oriented and able to work in a fast-paced environment while managing multiple priorities.
Experience supporting literature surveillance, safety reporting, signal management, or risk management activities is advantageous.
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What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
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