Senior Director, Global Qualified Person for Pharmacovigilance (QPPV)

Job Description

Position Summary: Deciphera B.V. is seeking a Sr. Director, Global QPPV to oversee pharmacovigilance activities for medicinal products in the EU/UK and other global countries. The role involves ensuring compliance with legal requirements, maintaining the Pharmacovigilance System Master File (PSMF), and managing safety profiles and emerging safety concerns.

Key Responsibilities:

• Serve as QPPV in the EU,UK and other global countries, as assigned, acting as a single contact point for competent authorities.
• Ensure oversight of PV in other countries and regions.
• Maintain oversight of safety profiles and emerging safety concerns.
• Provide input into regulatory actions and risk management plans.
• Ensure compliance with pharmacovigilance legal requirements and GVP.
• Review and approve PSMF, PV policies, and procedures.
• Promote and improve compliance with legal requirements.
• Oversee training curricula for PV staff and local PV systems.

Qualifications

Qualifications:

• 15+ years of PV experience, with at least 5 years as QPPV.
• Prior EU QPPV experience at Sr. Director level.
• Bachelor's/Advanced degree in life science, nursing, pharmacy, or other healthcare-related profession.
• Fluent in English (written and spoken).
• Reside and operate in the EU or UK.

Additional Information

Benefits:

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
• Generous parental leave and family planning benefits.
• Outstanding culture and opportunities for personal and professional growth.

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