Saftey Scientist
Safety Scientist ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. As a Safety Scientist at ICON, you will design and analyze clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies. What You Will Do: You will contribute to scientific operations activities, taking responsibility for your deliverables and working collaboratively. Key responsibilities include: Support GRMSS Physicians and GRMSS Scientists and aid in the coordination and preparation of Safety Management Team meetings.
- Provide support as needed to the GRMSS Physicians in review of periodic literature for new and
important information regarding Incyte products.
- In collaboration with the GRMSS Physicians/Scientists, support the preparation of Development
Safety Update Reports (DSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Periodic Adverse Experience Reports (PAERs), and updates to Risk Management Plans (RMPs) for Incyte clinical trial programs and marketed products.
- Participate in internal safety process improvements and updates.
- Contribute to preparedness for regulatory authority inspection and internal audits of Incyte
Pharmacovigilance by following standard operation procedures and processes.
- Provide overall support to the GRMSS Physicians and GRMSS Scientists for global risk management
and safety surveillance activities. Your Profile:
- Healthcare degree (e.g., BSN, CRNP, Pharm.D.) preferred (or relevant scientific degree buttressed by
industry experience).
- Two to four years of Pharmacovigilance/Drug Safety experience required.
- Experience analyzing safety case reports for the purpose of preparing aggregate safety reports
(DSURs, PADERs, PBRERs), signal detection and evaluation, and responding to queries by regulatory authorities required.
- Experience incorporating safety findings into aggregate reports (DSURs, PADERs/PAERs, PBRERs)
required.
- Fluency in written and spoken English.
- Experience in pharmaceutical industry activities involving health authorities in the United States and
across Europe.
- Experience in pharmacovigilance relating to oncologic or inflammatory diseases, or relating to
clinical support of oncology, immunomodulatory, or other related products preferred. Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: Competitive base salary and performance related incentives Health and wellbeing programmes including medical, dental, and vision coverage where applicable Retirement and pension plans Life assurance and disability coverage Employee assistance programmes and wellbeing resources Learning and development opportunities through structured training and career pathways Benefits may vary depending on role and location. Visit our careers site to read more about the benefits ICON offers. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here. Are you a current ICON Employee? Please click here to apply Apply To This Job