Global Patient Safety Compliance Manager

il y a 1 semaine

Paris, Île-de-France Ipsen Temps plein 50 000 € - 100 000 € par an

Are you ready to lead and innovate in a dynamic, patient-focused biopharmaceutical company?
Ipsen is a growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients' health and quality of life, providing effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases.

Why Ipsen?

  • Patient-Focused: The patient is at the heart of everything we do, and improving their outcomes is the deliverable of every strategy.
  • Employee Care: We care for our employees, who are the ambassadors making a real difference.
  • Bold Leadership: We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions.
  • Growth Opportunities: We offer a wealth of fulfilling challenges and growth opportunities in a fast-moving, game-changing organization.

About The Role
Within the Global Patient Safety (GPS) Department the
Compliance Manager
plays a key role in the management of the compliance activities.

Key Responsibilities
PSMF activities

  • Leading the management of the EEA PSMF activities including management and coordination of the periodic updates of the EEA PSMF.

Quality events and Change controls

  • Coordination of the management and follow-up of the GPS deviations (Quality Event) and of the CAPAs.
  • Coordination of the Change Control activit

Other GPS Compliance Activities

  • Maintenance and update of the safety regulatory intelligence system to monitor any PV regulations updates,
  • Contribution to the audit and inspection readiness and support in the preparation, conduct and follow-up of inspections and audits.
  • Maintenance and continuous improvement of the PV quality system by the monitoring of the Performance Indicators (PIs/KPIs).

EHS Responsibilities

  • Comply with applicable EHS regulations and procedures.
  • Participate in the site's EHS performance by reporting risks, malfunctions or improvements

Qualifications

  • Pharmacist or Master's Degree in Natural Sciences
  • Strong experience within Patient Drug Safety, Pharmacovigilance Quality Assurance and/or Pharmacovigilance
  • Advanced understanding of quality and pharmaceutical regulatory compliance
  • Advanced knowledge and understanding of Pharmacovigilance principles and regulatory guidelines.
  • Demonstrated knowledge of GVP requirements
  • Thorough and technical understanding of PV systems, processes and databases.
  • Fluency in English

If you feel that this could be the right next step for you, we would be delighted to engage with your application.

Ipsen is committed to fostering a diverse and inclusive workplace where all employees feel valued and empowered. If you feel that this could be the right next step for you, we would be delighted to engage with your application.

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