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.

• 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.

• Master’s degree in pharmacy, nursing, healthcare or other life-science or technical field (Pharm
  
  D 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
• Flue…