Location
Remote
Salary
Not specified
Type
fulltime
Posted
Today
Job Description
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.
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.
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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