Senior Pharmacovigilance Associate

🕒 May 26

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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

• Leading the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies. • Conducting thorough data analysis and interpretation of safety data, identifying trends and potential safety signals that require further investigation. • Preparing and submitting comprehensive periodic safety update reports (PSURs) and other regulatory documents, ensuring compliance with international regulations. • Collaborating with medical and clinical teams to assess the clinical relevance of reported adverse events and contribute to risk management activities. • Overseeing the maintenance and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards. • Providing training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices. • Engaging in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements. • Staying informed on evolving regulatory guidelines and industry best practices to continually enhance the pharmacovigilance processes within the organization.

🎯 Requirements

• Bachelor’s degree in life sciences, pharmacy, nursing, or a related field. • An advanced degree is preferred. • 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. • Proficiency in pharmacovigilance databases and data management systems, as well as Microsoft Office Suite. • Trilingual, with required proficiency in Portuguese, Spanish, and English. • At least 2 years of experiences in case processing and resolution.

🏖️ Benefits

• Various annual leave entitlements • A range of health insurance offerings to suit you and your family’s needs. • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. • Life assurance • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.