Senior Pharmacovigilance Associate

About the Role

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re dedicated to fostering an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are seeking a Senior Pharmacovigilance Associate to lead pharmacovigilance activities, ensure the safety and efficacy of pharmaceutical products, and drive compliance across projects. The role involves ownership of case processing, team coordination, training, audits, and collaboration with cross-functional teams to deliver high-quality safety outcomes. What You'll Do

• Lead the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies.
• Perform case processing for serious adverse events, serious and non-serious adverse drug reactions, and other medically-related project information, such as adverse events of special interest, clinical endpoints and medical information inquiries, literature surveillance, and data retrievals from the safety database.
• Serve as Functional Lead on case processing projects as assigned; coordinate teams of Pharmacovigilance associates on project level and serve as the Pharmacovigilance point of contact for project teams.
• Liaise with other ICON departments, investigational site, reporter, and/or Sponsor as necessary regarding safety issues.
• Responsible for effective and efficient development of the Safety Management Plan, including development of specific processes to assure consistency within the project.
• Report project status (including monthly metrics) to project/functional management within agreed upon timelines.
• Adhere to financial and administrative processes, such as managing project budget and timelines, estimation of resource needs and projected hours.
• Effectively coach and mentor less experienced Pharmacovigilance associates.
• 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.
• Overseeing the maintenance and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards.
• Engaging in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements. What We're Looking For
• 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.
• Experience coaching and mentoring less experienced Pharmacovigilance associates.
• Experience in audits and inspections is a plus. Nice to Have
• Experience coaching and mentoring less experienced Pharmacovigilance associates. Compensation & Benefits
• Competitive salary and benefits.
• Various annual leave entitlements.
• A range of health insurance offerings.
• Competitive retirement planning offerings.
• Global Employee Assistance Programme (LifeWorks) offering 24-hour access to a global network of professionals.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
• Visit our careers site to read more about the benefits ICON offers.

ICON is committed to inclusion and belonging, providing an inclusive and accessible environment for all candidates. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.