Pharmacovigilance Manager

We are currently seeking a Manager, Pharmacovigilance to join our diverse and dynamic team. Withing this position at ICON, you will be responsible for overseeing a variety of pharmacovigilance activities, ensuring the safety and efficacy of clinical trial products throughout their lifecycle, ensuring compliance with regulatory requirements and and fostering a culture of safety and quality within our organization. What You Will Be Doing:

• Support the on-going growth of the PV team in a senior capacity, mainly as an individual contributor.
• Creating budgets and proposals, specifying them for PV standalone projects.
• QPPV, literature reviews and providing local PV support.
• Developing and implementing pharmacovigilance processes and policies to enhance the efficiency and effectiveness of safety monitoring activities.
• Collaborating with clinical, regulatory, and quality assurance teams to ensure comprehensive safety assessments and timely reporting of safety data.
• Providing training and guidance to team members and stakeholders on pharmacovigilance regulations, practices, and procedures.
• Monitoring and analyzing safety data trends, preparing risk assessments, and presenting findings to relevant stakeholders.
• Ensuring that all pharmacovigilance activities are conducted in accordance with global regulatory requirements and internal quality standards.
  
  Bachelor's degree in life sciences, pharmacy, or a related field is preferred, with extensive experience in pharmacovigilance or drug safety management.
• A passion for PV is required, broad knowledge and the ability to work comfortable in a standalone role.
• Proven experience in managing pharmacovigilance teams and activities, with a thorough understanding of regulatory requirements and safety reporting standards.
• Experience of creating budgets and proposals, and literature review
• Strong analytical skills, with experience in assessing safety data and preparing safety reports for regulatory submission.
• Excellent leadership and organizational skills, with the ability to manage multiple projects and deliver results in a fast-paced environment.
• Exceptional communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders.
• Detail-oriented, proactive, and committed to maintaining the highest standards of safety and quality in pharmacovigilance operations.
  
  ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
  
  What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include:
• 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.