PV Manager, Southern Cluster

hace 7 días

Madrid, Madrid, España Kyowa Kirin International A tiempo completo

Overview:

WE PUSH THE BOUNDARIES OF MEDICINE.

LEAPING FORWARD TO MAKE PEOPLE SMILE

At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We're an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.

Job Purpose

The Southern Cluster PV Manager shall ensure the implementation, management, oversight and control of local PV activities in Spain, Italy and Portugal, in compliance with local PV regulatory requirements.

He/she will also act as the National PV Contact Point and Local Safety Officer for Spain.

He/she will oversee local PV vendor's activities in the Southern Cluster, including monitoring its performance and compliance.

The Southern Cluster PV Manager will also support the EU QPPV in the management and oversight of designated regional PV activities.

Responsibilities:

Key Responsibilities:

  • Regulatory compliance
  • ICSR management and safety data collection
  • Monitoring of Local Literature and Digital Media
  • Safety Communication and Signal Management
  • Safety Surveillance and Risk Management
  • Development and Maintenance of Local PV Procedural Documents
  • PV Training
  • Audit and Inspection Management
  • PV Business Continuity Plan
  • Local PV vendor management and oversight
  • Support QPPV Office activities in relation to interface with distribution partners for PV oversight.

Qualifications:

Position Requirements

  • University degree in Life Science (Pharmacy degree or equivalent)
  • Over 5 years of relevant experience in pharmacovigilance in the pharmaceutical industry (international experience desirable)
  • Expert knowledge of European and local laws and regulations in the countries of responsibility (i.e. local and EU PV regulations, ICH Guidelines, and GxP requirements).
  • Fluent in English and Spanish, both verbal and written
  • Strong analytical, organizational, and communication skills

Kyowa Kirin International is an equal opportunities employer.

No agencies please.

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