Senior Director Global Qualified Person for Pharmacovigilance QPPV
Senior Director Global Qualified Person for Pharmacovigilance QPPV
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Salary Not Disclosed
1 Vacancy
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 EUUK 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.
- Bachelors/Advanced degree in life science nursing pharmacy or other healthcarerelated 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.
Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
