Manager, Pharmacovigilance

As a Manager Pharmacovigilance you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

You will be partnering with a pharmaceutical company committed to discovering and developing treatments that improve and save people´s lives. Working in this program you will feel challenged and supported to advance in your professional career while making a truly impact.

What you will be doing:

• Manages personnel within Pharmacovigilance and has expertise with regards to the tasks of the subordinated group (E.g. may provide services for Serious Adverse Events (SAE)/Adverse Reactions /Medical Device Report management, periodic safety reports, adjudication, coding, product complaints).
• Monitors projects to assure company profitability and associated project goals and objectives are being met
• Develops, implements, and monitors profitability, objectives and metrics of assigned group of direct reports.
• Supports departmental initiatives and development of SOPs, investigation of process related issues, consulting on safety processes, tools, and regulatory compliance.
• May serve as the main point of contact for the customer for the life-cycle of assigned stand-alone safety and medical information projects, and the main pharmacovigilance point of contact for assigned projects
• Provides technical oversight of the generation of project plans such as but not limited to Safety Management Plans (SMP) or SAE Reconciliation plans, in close cooperation with project team during set-up phase
• Liaises with other functional managers to ensure consistency of pharmacovigilance approaches within the company
• Reviews 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.
• Supports direct reports in identification of out of scope activities and process efficiency/improvement needs or implement contract amendments/change orders as required
• Performs metric collection and data analysis to support company efforts for continuous improvement in policies, procedures, and business processes.

You are:

• Bachelor’s degree (or higher) in a healthcare-related or life science field
• Solid experience at a senior level within Pharmacovigilance within a CRO or BPO
• Broad knowledge of clinical development and / or safety requirements from pre-clinical to post marketing.
• Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team
• Excellent Project Management skills
• Analytical mindset

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.

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. 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. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.