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Senior PV Compliance Officer

London, United Kingdom

  • Salary: £60000 - £60000 per year
  • Job type: Permanent
  • Posted: 25/02/2019
  • Contact name: Matthew Jenner
  • Contact number: 0333 577 7578
  • Ref: 4067

Job description

Hobson Prior is seeking a Senior PV Compliance Officer for a global healthcare company that provides innovative and effective healthcare solutions. This Senior PV Compliance Officer will report into the Head of Pharmacovigilance and Medical Information and will provide expertise, strategy as well as a hands-on approach to setting up a regulatory compliant PV system. This role is a permanent position and will be based in Uxbridge, London.

Responsibilities:

  • Preparation of global Pharmacovigilance related procedural documents;
  • Support the Local Pharmacovigilance Responsible in the preparation of local PV procedures;
  • Lead the activities to maintain and further develop the PV processes and systems to ensure the global PV system is compliant;
  • CAPA (corrective and preventive action) and deviation management;
  • Maintain knowledge of EU and other regional legislation;
  • Preparation and maintenance of the Pharmacovigilance System Master File (PSMF)
  • Provide input in the preparation of enquiries from the Regulatory Authorities as required;
  • Preparation, negotiation and maintenance of Pharmacovigilance agreements;
  • Maintain inspection readiness for audits and inspections; take part in the preparation and help conduct Pharmacovigilance inspections/audits; support timely execution and submission of responses to inspections/ audits findings; maintain inspection/audit related documentation;
  • PV compliance management- preparation of ICSR compliance, aggregate reports compliance, monitoring the implementation of the Risk minimisation measures etc. as required;
  • Prepare training materials and deliver Pharmacovigilance related training for internal and external parties

Key Skills:

  • Ability to work in an environment of rapidly changing priorities and workload; ability to manage multiple activities and assignments;
  • Ability to work both as a member of a team and in an independent, self-directed manner;
  • Ability to manage and organise work to meet timelines and to meet the attention of detail required to successfully complete assignments;
  • Ability to communicate effectively in English both orally and in writing;
  • Ability to maintain client and corporate confidentiality; ability to effectively negotiate with individuals at all levels of business;
  • Ability to make scientifically sound decisions;
  • Ability to effectively interact within the multi-national company;

 Requirements:

  • BSc or equivalent in a life-science
  • Minimum of three years on the job experience in PV compliance
  • Previous experience in preparation and hosting PV inspections and audits is desirable;
  • Experience of working to SOPs in a regulated environment;

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page

Hobson Prior is a leading life science recruiter focussed on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.