Drug Safety Associate

đŸ”„ 3 minutes ago

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Logo of ICON plc

ICON plc

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕ Healthcare Insurance

Pharmaceuticals ‱ Biotechnology ‱ Healthcare Insurance

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

‱ Collect and review adverse event reports from clinical trials and post-marketing sources ‱ Conduct initial assessment and coding of adverse events according to established procedures and regulatory guidelines ‱ Prepare and submit expedited safety reports to regulatory authorities and investigators as required ‱ Assist in the development and maintenance of safety databases and tracking systems ‱ Collaborate with cross-functional teams to ensure timely and accurate reporting of safety data

🎯 Requirements

‱ Bachelor's degree in a scientific or healthcare-related field ‱ 1-2 years of experience in pharmacovigilance or drug safety within the pharmaceutical or biotechnology industry preferred ‱ Knowledge of pharmacovigilance regulations and guidelines (e.g., ICH, FDA, EMA) ‱ Strong attention to detail and ability to work effectively in a fast-paced environment ‱ Excellent communication and organizational skills, with the ability to collaborate across teams and prioritize tasks efficiently ‱ Willingness to travel as required (approximately 10%)

đŸ–ïž 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

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