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Deputy EUQPPV (m/w) - Hessen

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Deputy EUQPPV (m/w) - Hessen

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Deputy EUQPPV (m/w) - Hessen

Work 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.

  • 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

  • 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: +49 (0) 89 5519 7711, E: j.ecker(at)prlifesciences.com

Für mehr Informationen über Progressive Recruitment besuchen Sie www.progressive.de
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  • Unternehmen:
    Progressive Recruitment
  • Standort:
    Hessen, Hessen
  • Vertragsart:
    Vollzeit, Festanstellung
  • Branche:
  • Berufsfeld:
    Medizin und Gesundheit
  • Occupations:
  • Relevante Berufserfahrung:
    2 bis 5 Jahre
  • Karrierestatus:
  • Abschluss/Grad der Ausbildung:
  • Referenz-Code:
  • Posted:
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