Pharmacovigilance Compliance and Safety Operations Manager

Wat ga je doen?

What you'll be doing...

Safety Operations

• Ensure that pharmacovigilance daily operations, including adverse event case processing, global literature search and submission of ICSR to Health Authorities worldwide comply with regulations.
• Manage global vendor in charge of the Global Safety Database to convert GPS business needs into user requirements and deliverables that will assist in defining and validating the configuration of the end solution.
• Manage global vendor in charge of the Global Safety Database ensuring that any quality deviation and or miss of KPIs is properly addressed and a CAPA is initiated if needed.
• Determine root causes of nonconformance and assist in developing effective problem solution strategies to ensure compliance with safety information reporting to HAs worldwide.

GPS PV Audit and Inspection readiness

• Responsible and accountable for leading and or support in responding to PV audits/inspections (including North America) and for opening corrective actions/preventive actions (CAPAs) for Safety Operations activities.

PV System Compliance and GPS QMS:

• has oversight responsibility of GPS QMS documents management and training processes, for Safety Operations, PV Technology and Data Management activities, including strategy and compliance, use of BAXU, GPS training assignments and training metric reports.
• has oversight for any agreement withs vendors related to Safety Operations and PV Technology and Data Management activities

Wat vragen wij?

What you'll bring...

• Master’s Degree in life science with at least 5 years in safety vigilance/Pharmacovigilance
• Working experience with team management
• Strong knowledge of Pharmacovigilance Safety Systems (ARGUS, or other safety database applications) and electronic data capture systems.
• Excellent interpersonal skills that encourage teamwork
• Ability to work under strict deadlines and changing priorities and ability to multitask and prioritize changing workload for self and others
• Problem Solving- Identify priorities and key issues in complex situations, and formulate and execute issue resolution with minimal assistance
• Broad knowledge/understanding of relevant ICH guidelines, as well as FDA and EU Regulations
• Ability to interact effectively in a multifunctional and multicultural team setting.
• Experience working within a quality system to develop and optimize processes.
• Experience on PV vendor management.
• Ability to collaborate effectively in a complex matrix organization.
• Excellent analytical and problem-solving skills.
• Mature personality with excellent leadership and interpersonal skills
• Leadership experience in managing direct and shared resources, some at a geographic distance.
• Cultural sensitivity, patient but persuasive, cultural fit with values.

Wat bieden wij?

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