Regional Pharmacovigilance Senior Manager

Senior Manager Pharmacovigilance

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/Regional Pharmacovigilance Senior Manager to join our diverse and dynamic team. As the Senior Manager in this role at ICON, you will be responsible for overseeing pharmacovigilance activities to ensure assigned project(s) run(s) as per client requirements. Your leadership will be critical in maintaining compliance with regulatory requirements and enhancing the overall safety monitoring processes across the organization.

What You Will Be Doing:

• Serve as scientific expert and pharmacovigilance resource to external and internal partners within the region.
• Assess current processes to ensure adherence to applicable regulatory requirements and, where needed, enhance and/or develop new processes while assuring consistency with client standards. 
• Support the Head of Regional PV and EU/UK QPPV and the Regional PV Leads in the harmonization of processes across the regions.
• Liaise between the global functions, the affiliates and Business Partners  (overall Territories: EU, Canada, Australia, US, Japan and Brazil, MENA, South Korea, China, Singapore)

• Support the Head of Regional PV and EU/UK QPPV and the Regional PV Leads in the management of innovation projects for increasing Regional Team efficiency.
• Support the Regional PV Leads in the establishment and maintenance of the applicable pharmacovigilance system specific to the country/region
• Support the Regional PV Leads in the revision of documents pertinent to Regional PV tasks
• Promote increased awareness of and ensure compliance with pharmacovigilance obligations for the country/region.
• Contribute to the Pharmacovigilance System Master File (PSMF) data collection in any applicable country/region
• Contribute to increase the visibility of the GPS team/function throughout.
• Closely collaborate with other functions including regulatory, marketing, medical, communications, quality, legal, as well as other teams as needed. 
• Develop relationships with cross functional teams as it relates to adverse event reporting and other pharmacovigilance activities.
• Maintain an in-depth knowledge of local regulations, expectations and regulatory authority contacts and perform activities related to the interpretation and review of existing and evolving safety requirements.
• Actively participate in GPS audit and inspection readiness, support, and management together with the GPS Quality Management team and the Quality team.
• Maintain knowledge of the Company product portfolio and disease areas for marketed drugs and drugs in development.
• Contribute to the development and evaluation of Key Performance Indicators as related to pharmacovigilance as it relates to the assigned tasks.
• Drive Continuous Improvement initiatives as needed.
• May perform other tasks as appropriate.

Your Profile:

• Master’s degree in pharmacy, nursing, healthcare or other life-science or technical field (PharmD or MD is a plus)
• At least 7-12 years of experience in the pharmaceutical/biotech industry or at the regulatory authorities with at least 5 years in pharmacovigilance/drug safety
• Working knowledge of pharmacovigilance regulatory requirements and GVP guidance documents
• Knowledge of the drug development process, GXP quality and compliance requirements
• Earlier experience in managing PSMF is a plus
• Good presentation skills with the ability to communicate complex issues clearly
• Good planning and organizational skills with ability to manage competing priorities
• Good oral and written communication skills
• Ability to motivate, influence, and collaborate with multidisciplinary teams
• Ability to work independently and in a global environment and have experience of this
• Understanding of safety business processes and systems for the collections of adverse events
• Problem solving, conflict resolution and critical thinking skills
• Relevant computer skills, including proficiency with Microsoft Office Suite
• Fluency in written and spoken English
• Flexibility to travel as required for Client Meetings, Audits and Inspections

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.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here

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.

Are you a current ICON Employee? Please click here to apply