Pharmacovigilance Reporting Specialist

🔥 7 minutes ago

🌐 India, Mexico – Remote

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⏰ Full Time

🟡 Mid-level

🟠 Senior

👻 Ghost score 10%

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Logo of ICON plc

ICON plc

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

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

• Prepare and submit comprehensive safety reports, including periodic safety update reports (PSURs) and individual case safety reports (ICSRs), in compliance with regulatory standards • Conduct thorough data analysis to identify trends and assess the safety profile of pharmaceutical products • Collaborate with cross-functional teams to ensure timely and accurate reporting of adverse events • Maintain up-to-date knowledge of pharmacovigilance regulations and industry best practices to ensure compliance • Provide training and support to team members on pharmacovigilance reporting processes and requirements • Contribute to pharmacovigilance and drug safety activities, taking responsibility for deliverables and working collaboratively

🎯 Requirements

• Bachelor's degree in a relevant scientific discipline or healthcare-related field • Significant experience in pharmacovigilance reporting or drug safety within a clinical or pharmaceutical environment • Strong analytical skills with proficiency in data analysis tools and reporting software • Excellent communication and interpersonal skills, facilitating effective collaboration with internal and external stakeholders • A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities • Legal right to work in the country where the role is based

🏖️ 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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