Safety Operations Manager

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 global pharmacovigilance/drug safety (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