Saftey Scientist

ICON plc • Blue Bell, SD

5d

About The Position

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.

Requirements

• 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.

Nice To Haves

• Healthcare degree (e.g., BSN, CRNP, Pharm.D.) preferred (or relevant scientific degree buttressed by industry experience).
• Experience in pharmacovigilance relating to oncologic or inflammatory diseases, or relating to clinical support of oncology, immunomodulatory, or other related products preferred.

Responsibilities

• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree