ICON plc—Pharmacovigilance Reporting Associate

Job description

Description: Pharmacovigilance Reporting Associate (Submission) ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. As a Pharmacovigilance Reporting Associate at ICON, you will be responsible for the accurate and timely preparation of safety reports related to clinical trials and post-marketing activities. What You Will Do: You will take responsibility for pharmacovigilance and drug safety deliverables, applying your skills to ensure quality and efficiency. Key responsibilities include: - Preparing and reviewing safety reports, including periodic safety updates and individual case safety reports, ensuring accuracy and compliance with regulatory standards. - Collecting and analyzing adverse event data from clinical trials and post-marketing sources to support the preparation of comprehensive safety reports. - Maintaining up-to-date knowledge of regulatory requirements and industry best practices related to pharmacovigilance reporting. - Collaborating with cross-functional teams, including clinical, regulatory, and data management, to gather necessary information and resolve any reporting issues. - Ensuring the timely submission of safety reports to regulatory authorities and sponsors, adhering to established deadlines and guidelines. Your Profile: You will bring relevant pharmacovigilance and drug safety experience, along with the following qualifications and skills. Required qualifications and experience: - 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%) Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: - 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 Benefits may vary depending on role and location. Visit our careers site to read more about the benefits ICON offers. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here. Are you a current ICON Employee? Please click here to apply