ICON plc

Senior Regional Pharmacovigilance Manager

ICON plc

full-time

Posted on:

Location Type: Remote

Location: United Kingdom

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Job Level

Senior

About the role

  • 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.

Requirements

  • 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.
Benefits
  • 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
pharmacovigilancedrug safetyPSMF managementGVP guidanceGXP qualityregulatory requirementsadverse event reportingKey Performance Indicatorscontinuous improvementdrug development process
Soft Skills
presentation skillsorganizational skillsoral communicationwritten communicationcollaborationproblem solvingconflict resolutioncritical thinkingmotivationinfluence
Certifications
Master’s degree in pharmacyMaster’s degree in nursingMaster’s degree in healthcarePharmDMD