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Job Details

PW-6738 Compliance Auditor – GCP / PV (Manager/Senior Manager) QA

Company: AXESS
Location:
Reference: PW-6738
Closing Date: 08 Jan 17
Type: Permanent
Salary (£): Competitive
Benefits: Comprehensive befits package including stock options

Job Summary:

This is an exciting, autonomous role for a Compliance Manager (Auditor) or Senior Manager (Senior Auditor) position within this leading biopharma company’s Global R&D Compliance and Audit team. It is a key QA role with primary responsibility for planning and participating in global GCP and PV audits. This main focus is on auditing pharmacovigilance activities and processes.

Requirements:

BACKGROUND

Leading global biopharma company

This role can be office or home based (in any EU location)

Frequent travel (up to 40% to the EU / Asia /  North America / Australia and the Middle East)

Supportive team.

Lots of autonomy in role to organise your own diary

 

PRIMARY DUTIES

  • Key responsibilities include:
  • Plan, conduct and report routine and directed clinical trial, GLP and PV compliance audits
  • Audit of safety and PV activities of outsourced service providers and affiliates
  • Identify and communicate compliance risks to the group management
  • Host and/or play a lead role in regulatory authority inspections
  • Lead process improvement initiatives
  • Author and contribute to the development of group cross functional controlled documents

 

QUALIFICATIONS / EXPERIENCE REQUIRED

Preferred Qualifications:

  • Bachelor’s degree in related discipline

Experience required:

  • International auditing experience in PV. Candidates with GCP auditing experience with some PV auditing as a secondary discipline will also be considered.
  • For the Senior Manager level in-depth experience and knowledge of PV auditing as well as experience leading complex audits is required.
  • Knowledge of regulations applicable to area of technical expertise
  • Knowledge of clinical development and PV process and operations
  • Knowledge of audit/compliance program design and audit methodology
  • Knowledge of GLP/PV and GCP
  • Experience supporting regulatory authority inspections
  • Participation in process improvement initiatives

 

Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.

 

TO APPLY

 

For a confidential discussion please telephone Rebecca Bray at AXESS Limited on 020 8560 2300. To apply, please send your CV to jobs@axess.co.uk quoting reference PW-6738

 

Keywords:

PV, Pharmacovigilance, jobs in Middlesex, Jobs in London, Global Pharma, Auditing, PV auditing, GCP Auditing, GCP, GLP, Safety Evaluation, Medical Review, Compliance Auditor, PV compliance auditor, pharmacovigilance auditor, QA, quality assurance

 

 

ABOUT AXESS

AXESS has been operating since 1990

We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development

We match professional candidates to the best permanent, contract and interim roles in the market

Visit us at www.axess.co.uk

 

 

Apply for this job:  PW-6738 Compliance Auditor – GCP / PV (Manager/Senior Manager) QA

Contact Information:

Address:  Head Office
Isabella House,
12 Union Court,
Richmond upon Thames,
Surrey
TW9 1AA
England
Tel:  +44 (0)20 8560 2300
Fax:  +44 (0)20 8560 2033
Website:  Visit Our Web Site

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