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Senior PV Officer

Senior PV Officer

  • Location

    Berkshire, England

  • Sector:

    Pharmacovigilance

  • Job type:

    Permanent

  • Salary:

    Up to £44000 per annum

  • Contact:

    Joe Haskell

  • Contact email:

    info@pharma-partners.co.uk

  • Job ref:

    13651_1550226742

  • Published:

    over 1 year ago

  • Expiry date:

    2019-03-17

  • Startdate:

    ASAP

  • Consultant:

    #

Senior Pharmacovigilance Officer

A speciality pharmaceutical company in Berkshire is seeking a Senior Pharmacovigilance Officer. This role with will have responsibility for pharmacovigilance for all company products, ensuring company compliance inline with MHRA/EU regulations and to provide training in matters of drug safety and medical/product information.

Responsibilities:

  • Generation of PSURs in line with UK/EU requirements and Maintains PSUR schedule.
  • Prepares expedited report and handles AE follow-up requests
  • Support PV Manager in developing and executing QA PV strategy and implementing associated Quality Management System
  • Contribute to evaluation of corrective and preventative action (CAPA) findings to identify quality-related signals and trends for improvement
  • Reconciliation of ADR and MI reporting.
  • Contribute to the development and implementation of strategic audit plans for pharmacovigilance activities that include service providers, vendors, business partner, and internal audits

Requirements:

  • Experience in EU pharmacovigilance within either a research and development or established products environment
  • Case Processing and drug safety report writing experience
  • Knowledge of Good Pharmacovigilance Practices (GVP), Good Clinical Practice (GCP), Good Distribution Practices (GDP), and Good Laboratory Practices (GLP)
  • Relevant experience in the pharmaceutical industry
  • Extensive Compliance, Quality and auditing experience.

Salary and benefits:

  • Competitive salary and bonus
  • Extensive benefits package