Regional Pharmacovigilance Senior Manager

• 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 (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
• 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

Earlier experience in managing PSMF is a plus

• 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