Beschreibung
Deputy EUQPPV (m/w) - HessenWork as "Deputy EUQPPV (m/w)" at a global leader in the plasma protein biotherapeutics industry in Hessen, Germany. The position includes a wide range on responsibilities and provides a lot of variation.
Responsibilities:
- Support the EU-QPPV in all aspects and take over full EU-QPPV accountability when the EU-QPPV is absent
- Deputizes for all managerial tasks and responsibilities for the QPPV Office
- Takes the lead for targeted investigations and improvement initiatives as per delegation by the QPPV
- Accountable for keeping specific parts of the Pharmacovigilance System Master File up to date and ensure compliance
- Contribute to and coordinate communications to the Regulatory Authorities relating to safety and pharmacovigilance matters and coordinates responses to any request from Regulatory Authorities for (further) information
- Critical review of benefit-risk evaluation, aggregate reports and planned RM measures
- Oversight over PV operations and PV systems such as but not limited to
- Safety Database and ICSR receipt and reporting
- Regions
- PV Agreements
- PV Quality Management and respective compliance as delegated by the EU-QPPV
- Supports the EU-QPPV in ensuring global inspection readiness at all PV sites through regular review of the pharmacovigilance system including its quality system and takes a risk- based approach when designing and implementing CAPAs.
- Closely cooperates with the affiliates and GCSP Regions in order to ensure compliance and inspection readiness
- Deputizes the EU-QPPV in the Global Safety Governance system, specifically in the Global Safety Review Team (GSRT) and Global Safety Committee (GSC).
Your profile:
- Medical Doctor with working experience as a physician minimum 3 years working experience in the Pharmacovigilance
- Excellent knowledge of regulations, particularly EU Significant service within a global Pharmacovigilance function
- Good knowledge in Risk Management
Advantages:
- International company
- Intercultural Team
- flexible working time
- Home office
- attractive salary
- withinthenextyearsdevelopmenttotheEUQPPV
As a Recruitment Consultant in the area Drug Safety, I would like to give you more information about that vacancy and will assist you in the complete application process.
If you are interested in that vacancy, I look forward to your email with an actual CV and an proposed date for a phone call.
Julia Ecker, T: , E:
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