Senior Manager, Pharmacovigilance

Senior Manager, Pharmacovigilance - Hybrid - Sofia, Bulgaria or Warsaw, Poland

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

We are currently seeking a Senior Manager, Pharmacovigilance to join our diverse and dynamic team. As the Senior Manager in this role at ICON, you will be responsible for overseeing pharmacovigilance reporting activities to ensure the safety and efficacy of our clinical trials. Your leadership will be critical in maintaining compliance with regulatory requirements and enhancing the overall safety monitoring processes across the organization.

This role is office-based and requires 60% office attendance, 40% can be remote.

What You Will Be Doing:

• Monitoring projects to assure company profitability and associated project goals and objectives are being met.
• May serve as the main point of contact for the customer for the life-cycle of assigned stand alone projects and programs, and the main pharmacovigilance point of contact for assigned full-service projects.
• Identifying and implementing process improvements and other ways to improve efficiencies.
• Managing the pharmacovigilance reporting team to ensure timely and accurate reporting of adverse events and safety data in compliance with regulatory standards.
• Managing resources and resource projections to ensure project teams are consistent with client needs, expectations and contractual obligations.
• Analyzing current and future project backlog in order to provide adequate resources to meet business objectives.
• Reviewing Pharmacovigilance (Reporting) Associate, Pharmacovigilance (Reporting) Specialist and/or Pharmacovigilance Assistant, Pharmacovigilance (Senior) Project Manager group-related project tasks; provides leadership in the delivery of related services to clients.
• Supporting direct reports in identification of out of scope activities and process efficiency/improvement needs or implement contract amendments/change orders as required.
• Developing and implementing pharmacovigilance policies and procedures to enhance safety monitoring and risk management practices.
• Collaborating with cross-functional teams, including clinical operations and regulatory affairs, to ensure integration of safety data into clinical development plans.
• Monitoring and analyzing safety data trends to identify potential risks and inform decision-making for ongoing clinical trials.
• Staying updated on industry regulations and best practices in pharmacovigilance reporting to drive continuous improvement initiatives.
• Supporting the development and implementation of training for Pharmacovigilance (Reporting) Associate, Pharmacovigilance (Reporting) Specialist and/or Pharmacovigilance Assistant or other personnel within Pharmacovigilance.
• Recommending and supporting implementation of performance and productivity improvements within assigned service area to ensure optimal utilization of billable staff.
• Performing metric collection and data analysis to support company efforts for continuous improvement in policies, procedures, and business processes.
• Building teamwork and improves process and productivity by working within and across functional areas.
• Ensuring staff development and performance feedback are provided through activities such as mentorship and career development.
• Involvement in the recruiting processes for new employees within the assigned service area.
• Participation in business development initiatives, including presentations and proposal development.
• Supporting direct reports and senior management during audit preparation and conduct. Responds to audit findings as needed.
   

Your Profile:

• Degree in life sciences, pharmacy, or a related field; advanced degree or relevant certifications are preferred.
• Significant (5+ years) experience in pharmacovigilance or drug safety reporting, ideally within the clinical research or pharmaceutical industries.
• Previous line management experience as well as experience in managing PV reporting projects (ideally 2+ years).
• Strong understanding of regulatory requirements related to drug safety and reporting.
• Excellent analytical and problem-solving skills, with a focus on data-driven decision-making.
• Strong communication and interpersonal skills, capable of engaging and influencing diverse stakeholders.
• Excellent command in English.

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What ICON can offer you:

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