Offer summary

Qualifications:

Bachelor’s or Master’s degree in nursing, healthcare, life-science or relevant field., Minimum of 5 years of experience in Safety/Clinical Research/Pharmacovigilance., Advanced knowledge of global pharmacovigilance regulations and safety database systems, particularly ARGUS., Proven ability to communicate effectively in English and collaborate with internal and external stakeholders..

Key responsibilities:

Oversees operational delivery and coordination with safety vendors and GPS teams for case processing and reporting.

Collaborates with internal teams and external parties on safety-related deliverables and processes.

Communicates with clients and business partners regarding safety data exchange agreements.

Identifies issues for improvement, engages in process development, and ensures compliance with regulations.

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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

Required profile