Senior Pharmacovigilance Associate

🕒 June 10

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ICON plc

WebsiteLinkedInAll Job Openings

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

• Lead the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies • Conduct thorough data analysis and interpretation of safety data, identifying trends and potential safety signals that require further investigation • Prepare and submit comprehensive periodic safety update reports (PSURs) and other regulatory documents, ensuring compliance with international regulations • Collaborate with medical and clinical teams to assess the clinical relevance of reported adverse events and contribute to risk management activities • Oversee the maintenance and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards • Provide training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices • Engage in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements

🎯 Requirements

• Bachelor's degree in a relevant scientific discipline or healthcare-related field • Extensive experience in pharmacovigilance or drug safety, with a strong understanding of relevant regulations and industry standards • Proven ability to manage the pharmacovigilance process effectively, including adverse event reporting and signal detection • Strong analytical and critical thinking skills, with the ability to interpret complex data and make informed recommendations • Excellent communication and interpersonal skills, with the ability to work collaboratively across cross-functional teams • Proficiency in pharmacovigilance databases and data management systems, as well as Microsoft Office Suite • Ability to work independently and manage multiple priorities in a fast-paced environment • Willingness to travel as required (approximately 15%)

🏖️ 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