CAREERS

Senior Pharmacovigilance (PV) Auditor

Location: Guildford, UK

PrimeVigilance is continuing to expand and is looking for a Senior Pharmacovigilance Auditor to join our dynamic and rapidly expanding organization.

The PV Auditor will be responsible to effectively manage and conduct internal and external (third-party) audits to assure compliance with applicable PrimeVigilance´s and/or Client´s procedures and local and global regulatory requirements as well as contractual agreements.


Key Accountabilities

Auditing activities

  • Effective management of pre-audit activities: Communication with Auditee, preparation of Quality plan, Audit plan, Audit checklist, etc. in agreed formats and timelines;
  • Conduct pharmacovigilance audits initiated by PrimeVigilance, according to the agreed Audit Programme and in line with agreed Audit plan and Quality plan:
    o Audits of Partners and Service Providers;
    o Audits of Projects and Activities.
  • Conduct Audits of Third Parties (TP) on behalf of Clients in line with agreed Audit plan and Quality plan and Client´s specification;
  • Document audit findings and recommendations and identify process improvement initiatives and document them in an Audit report in agreed formats and timelines;
  • Plan, create and maintain Corrective and Preventative Action Plans if needed, on an assigned audit basis;
  • Generate and monitor audit metrics and performance evaluation.
  • Act as Lead Auditor on an assigned audit basis: Manage Audit Team in the performance of pharmacovigilance audits, ensuring that audits comply with applicable PrimeVigilance and/or client´s procedures and local and global regulatory requirements as well as contractual agreements.

General activities

  • Support audits and inspections of PrimeVigilance performed by clients/third parties and regulatory authorities;
  • Participate in preparation (authoring or QC) of audit strategy, SOPs, guidelines and other documented procedures required for auditing activity of PrimeVigilance and/or Client as per operational needs;
  • Keep up-to-date about the relevant regulations, legislation of Pharmacovigilance, participate in relevant seminars and trainings;
  • Participate in workshops or trainings organised by PrimeVigilance and create/develop and present training to PrimeVigilance staff on applicable regulatory requirements;
  • Perform other activities as required by the company management in the area of responsibilities and qualifications as stated above.

Qualifications and Skills
  • University education in life sciences or healthcare
  • Strong experience in Pharmacovigilance
  • Previous auditing experience
  • Knowledge of EU and FDA Regulations as well as Guidelines on Good Pharmacovigilance Practice (GVP) and ICH Guidelines
  • Advanced knowledge of standard 19011:2011 and its principles, rules, key points, ethics and objectives, would be a plus, but not required
  • Quality-oriented, quality-committed
  • Excellent interpersonal and communication skills, including good presentation and report writing skills
  • Meticulous attention to detail
  • Self-motivation, determination and confidence in own abilities
  • Ability to work to deadlines, under pressure
  • Ability to work on your own initiative and as part of a team
  • Fluent knowledge of English; additional languages would be a plus

Our Offer
  • Competitive salary
  • Work within a successful, highly – qualified and dynamic team
  • Professional training and career development in a fast growing healthcare company.

If you would like to be considered for this opportunity, please send your application via email to careers@primevigilance.com enclosing your English CV and Cover Letter.

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Thank you for your application. Unfortunately, because of the volume of applications we receive, we are not able to give status updates, but if you are invited for an interview, we will contact you directly.

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