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Job Details

**Pharmacovigilance Auditor - Hertfordshire!**

Company: Advanced Clinical Recruitment Ltd
Location: Hertfordshire
Reference: PV-Aud-UK
Closing Date: 15 Dec 16
Type: Full Time
Salary (£): Competitive
Benefits: Excellent Salary, Bonus and Package

Job Summary:

A well known and exciting Global Pharmaceutical company is looking for a PV Auditor to join the team based at their key Hertfordshire location. The role requires a professional who ideally has experience leading PV Audits, as well as someone who can provide extensive knowledge to the group from a PV perspective. The client can offer a strong base for progression as the group has seen growth and success over the previous years. This is a very a niche and exciting role.

Requirements:

Job Description:

  • Prepare and conduct internal and external audits for the company.
  • Provide independent review, comprehension, and discussion of departmental and corporate policies and procedures with multiple levels of employees and Management.
  • Provide interpretation of complex regulations through research of current corporate and governmental expectations and serve as a compliance reference regarding PV Interpretations for all levels of Management.
  • Provide guidance and support in the development of corrective actions based on PV principles and current industry standards.
  • Perform independent research of required topics and FDA, EMEA, TGA, Health Canada, WHO, PIC/S, MHLW, and other national, international, or supranational regulations (GxP and ICH) including assessment of applicability and impact on systems being audited.

  • Work with the Pharmacovigilance team to agree the annual audit schedule.
  • Work with contract audit provider to schedule internal and external audits.
  • Review and approve audit reports and CAPA plans resulting from audits that are contracted.

 

Requirements:

  • Minimum of a Bachelor's degree (or equivalent) and minimum of 6 years of pharmacovigilance operations and/or audit experience.  However, a combination of experience and/or education will be taken into consideration.
  • Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence.
  • Ability to perform computations such as percentages, ratios, and rates, as well as perform statistical analysis. Ability to draw and interpret graphical data. Ability to understand pharmaceutical calculations is preferred.
  • Must possess sound knowledge of national, international, and supranational cGMP regulations and expectations sufficient enough to readily interpret, lead discussion, and provide guidance based on the applicability of the regulations to the subject being audited. Must be familiar with all other GXP concepts
  • Must be articulate in both written and oral communications including diplomatic discussion of required corrective actions with business partners
  • Proficiency in speaking, comprehending, reading and writing English is required

 

For further information on how to progress your career through this excellent opportunity, within a fantastic organisation, please contact me ASAP for a completely confidential conversation! Alternatively, to apply directly, please send through an updated copy of your CV, and I will do the rest!

 

Sam Caley - Advanced Clinical Recruitment

+44 (0) 114 270 1741

scaley@acr-uk.com           

LinkedIn Search: Sam Caley Quality Assurance

 

Keywords: QA, Quality Assurance, GCP, GxP, GMP, GLP, Good Clinical Practice, Auditor, Audit, GCP Audits, Clinical Quality Assurance, Lead Auditor, Head or Quality, Senior Auditor, Senior Manager, Management, Audit Strategy, Structure, Home Based, Field Based, Pharmaceutical, Jobs in Pharma, Pharmaceutics, Generics, Specials, CRO, Pharmaceutical, Head of Clinical Quality, Global Quality Assurance, Head of Global, Clinical Operations, Clinical Development, Project Management, PVG

Apply for this job: **Pharmacovigilance Auditor - Hertfordshire!**

Contact Information:

Address:  Head Office
Regus 2nd Floor
The Portergate
Eccleshall Road
Sheffield
S11 8NX
England
Tel:  0114 270 1741
Website:  Visit Our Web Site

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