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QPPV Qualified Person of Pharmacovigilance

Russell Taylor Associates
Job LocationManchester
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Role: - QPPV (QP for Pharmacovigilance)Location: - Greater ManchesterSalary: - Highly CompetitiveRussell-Taylor Group have a brilliant opportunity for an EU-QPPV to join a fast-growing Pharmaceutical manufacturing company in the Greater Manchester area. If you a minimum of 5 years European QPPV experience and are looking for your next opportunity. Please apply within.Responsibilities

  • Management and maintenance of the companys pharmacovigilance system in compliance with the SOPS, regulatory requirements and DSA safety standards
  • Manage the daily pharmacovigilance activities of all direct reports in accordance with the company handbook.
  • Acting as a contact point for the EU Competent Authorities on a 24- hours/7 days basis with support of the Deputy QPPV
  • Ensure the quality, completeness and timeliness of reports submitted to European Regulatory Authorities
  • Ensuring prompt answers to requests of any information on the companys products by the EMA or EU national regulatory authorities
  • Having an overview of the safety profiles and any emerging safety concerns of the companys products
  • Dealing with urgent safety restrictions requested by the EMA or EU regulatory organisations
  • Preparation of periodic external audits to licence partners, internal audits, and any remedial plans
  • If there is any regulatory authority inspection, take the lead ensuring support and all the documentation requested by the inspectors is available for the to review
  • Support the revision of the company global SOPS to ensure the regulatory requirements
  • Provide appropriate training to relevant people on pharmacovigilance
  • Assist management team to ensure the sites KPIs are met
  • Ensure that the companys database meet the business requirements and remains compatible for the EuraGMBD database
  • Contractual arrangements: 3rd part licences, distributors, commercial and technical partners etc
    • The person
  • Previous EU-QPPV experience or Deputy EU-QPPV
  • 5 years experience minimum in all pharmacovigilance operational aspects
  • Experience in pharmacovigilance audits and inspections
  • Project Management experience with qualification (desirable)
  • Excellent working knowledge of the new drug safety requirements in Europe
  • Life Science degree (pharmacy or medicine)
  • Ability to interact with EMA, MHRA and other relevant authorities
  • Quality driven
  • Ability to support senior management
  • Flexible worker- Capacity to work independently and self-manage
    • Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy h t t p s : / / w w w . r u s s e l l - t a y l o r . c o . u k / p r i v a c y - p o l i c y on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or the GDPR please contact us on h r @ r u s s e l l - t a y l o r . c o . u k

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