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Saftey Scientist
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410 ICR United States USA
Blue Bell, PA (In Person)
Full-Time
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Job Description
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.
D.) preferred (or relevant scientific degree buttressed by industry experience).
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.
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.