PV Officer

  • Location

    Hertfordshire, England

  • Sector:

    Healthcare

  • Job type:

    Permanent

  • Salary:

    £30000 - £35000 per annum

  • Contact:

    Experis UK

  • Contact email:

    Paul.White@experis.co.uk

  • Job ref:

    PW/398_1600944156

  • Published:

    25 days ago

  • Expiry date:

    2020-10-15

  • Start date:

    ASAP

  • Client:

    #

OVERVIEW:

  • To ensure compliance with Good Pharmacovigilance Practice (GPvP)
  • The PV Officer/QPPV is appointed as the management representative for the Quality Management System (QMS) for PV. He/she is responsible for ensuring the requirements of the QMS are implemented and maintained in an effective manner.

KEY ACCOUNTABILITIES:

  • Maintenance of the PV specific QMS and associated documentation (e.g. PSMF, SOPs etc) and records (e.g. deviations, change controls, audit reports).
  • Act as system owner for the followingPV specificQMS components:
    • Internal Audits
    • Complaints, Medical Information Enquires, Adverse Event Reporting
    • Documentation / SOPs / Literature Reviews/ Product Safety Reviews
    • Deviations and Non-Conformances
    • Change Control
    • Corrective and Preventative Actions (CAPAs)
    • PSUR and RMP preparation and submission
    • Technical Agreements and SDEA Collation
    • Consulting with QPPV and medically qualified person on PV issues (when required)
    • Review of ICSR process and reports
    • Collating all adverse reports from various sources including ASPR's, Literature Search and Spontaneous reports
    • Electronic reporting to Health Authority
    • Pharmacovigilance Training (Inclusive of company Site Wide PV Training)
    • Provision of PV Activities for other specified MAH'S
    • XEVMPD new licences population in Eudravigilance
    • Implementation of European Medicines Agencies(EMA) Pharmacovigilance Updates
    • Deputising for specified duties in absence of QPPV (as specified in Pharmacovigilance SOP'S)
    • Participation in competent authority inspections
    • Ensure regular meetings are held with the Quality Assurance Team and implement decisions taken at the reviews.
  • Miscellaneous:
    • To comply with Health and Safety Regulations.
    • To maintain the confidentiality of all information relating to the business activities of the Company (and sister companies)
    • To attend relevant courses as demanded by the Company
    • To perform other duties as directed by the Company

SKILLS/EXPERIENCE REQUIRED:

  • Life Science Degree or several years' experience within a Pharmacovigilance department
  • Industry experience preferred.
  • Desirable: Eudravigilance system experience

Due to the high volume of applications we receive we are not able to get back to everyone who applies. Therefore if you have not heard back from Experis within 7 days please assume that your application has been unsuccessful however we will contact you if suitable roles come up that match your skill set.