Pharmacovigilance Reporting Associate

🔥 14 hours ago

🇮🇳 India – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

✨ Associate

👻 Ghost score 10%

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ICON plc

WebsiteLinkedInAll Job Openings

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 review safety reports, including periodic safety updates and individual case safety reports • Collect and analyze adverse event data from clinical trials and post-marketing sources • Maintain up-to-date knowledge of regulatory requirements and industry best practices related to pharmacovigilance reporting • Collaborate with clinical, regulatory, and data management teams to gather information and resolve reporting issues • Ensure timely submission of safety reports to regulatory authorities and sponsors

🎯 Requirements

• Bachelor's degree in life sciences, pharmacy, or a related field • Experience in pharmacovigilance or drug safety, with a strong understanding of safety reporting processes and regulatory requirements • Excellent attention to detail and organizational skills, with the ability to prepare and review complex safety reports accurately • Strong communication and collaboration skills, with experience working effectively within a multidisciplinary team • Ability to manage multiple tasks and prioritize effectively in a fast-paced, regulated environment • Willingness to travel as required (approximately 10%) • 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