Purpose:
- Oversees operational delivery and staff within Global Patient Safety (GPS) Operations, in accordance with the GPS vision, strategy and regulatory requirements.
- Interacts with and provides guidance to internal functions and external vendors as required for seamless GPS Operations
Reporting Line:
- Head of Global Patient Safety Operations or designee
Roles and responsibilities:
- Oversees and coordinates with safety vendor and GPS teams regarding case triage and processing, expedited and aggregate reporting
- Coordinates with and supports deliverables with GPS GSL team in relations to case processing
- Collaborates with other internal teams (including clinical, medical, or regulatory) and external parties (including HCPs, consumers, or contracted resources) regarding safety related deliverables and processes
- Communicates within client and with business partners or distributors regarding deliverables related to PV Agreements (PVA) / Safety Data Exchange Agreements (SDEA).
- Oversees assignment of Safety Specialist tasks, i.e. regarding timely monitoring of GPS communication
- Proactively identifies issues and areas for improvement and escalates appropriately
- Proactively engages in the development of new processes and procedures and leads implementation of those
- Performs all activities in compliance with applicable client Controlled Procedures and with global and local regulations as applicable.
- Performs other tasks as assigned by line manager or Head of GPS
Skills and Competencies:
- Advanced knowledge of medical terminology, pharmacovigilance processes and relevant regulations, including global requirements (e.g. EU, US, Japan)
- Proficiency with safety database systems (i.e. Argus) and MedDRA coding
- Advanced computer skills, including proficiency with Microsoft Office including Excel, Power Point, Visio
- Communicates complex issues in an understandable, effective and relevant manner
- Manages and prioritizes a variety of tasks for self and team to meet required deadlines
- Makes operational decisions with limited supervision and has a good understanding of the overall impact and potential risk
- Identifies complex problems, raises issues and proposes solutions constructively
- Proven ability to communicate effectively and collaborate successfully across functions and with vendors
- Advanced communication in written and spoken English required
Education, experience and qualifications:
- Bachelor's /Master's degree (or local equivalent) in nursing, healthcare or other life-science or relevant field
- Minimum of 5 years of relevant experience in Safety / Clinical Research / Pharmacovigilance
- At least 7 years of relevant experience in globalpharmacovigilance/drugsafety (EU&US)
- Equivalent and adequate combination of education and experience
- Advanced expertise of global (EU/US) pharmacovigilance requirements and practices
- Advanced experience with safety database systems (ARGUS preferred) including workflow management
- Proven experience in interaction with 3rd party vendors
- Proven experience with the identification of quality issues and evaluation of quality metrics
