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Job Details

GVP Compliance Audit Senior Manager

Company: ProClinical Ltd
Location: New Jersey
Reference: US.QA.MT.10411
Closing Date: 24 Jan 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

Our client is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. With a presence in more than 70 countries - and growing the organisations looks for talented people to progress the business in both scientific contribution and growth. They are seeking a GVP Compliance Audit Senior Manager to join their busy team in New Jersey, USA. ...

Requirements:

Our client is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. With a presence in more than 70 countries - and growing the organisations looks for talented people to progress the business in both scientific contribution and growth. They are seeking a GVP Compliance Audit Senior Manager to join their busy team in New Jersey, USA.

Job Role and Responsibilities:

  • The experienced Pharmacovigilance/Drug Safety Senior Manager would be responsible for leading and conducting complex process/system audits, affiliate/local operating company audits, and Contract/Licence Service Providers in areas such as drug safety, risk management, REMS.
  • They must be able to work diligently both within a global team setting and individual in the US New Jersey headquarters.
  • Audits will involve global travel, and process/system audits include such areas as aggregate reporting, signal detection, case processing, and Market Research.
  • There would also be overlap in the PV audit program with GCP (e.g. Investigator brochure, IIT processes), GMP (Product recall process, Medical Affairs) and CSV (ARISg database review).
  • On average the Senior Manager would be required to conduct around 6-8 audits each year, in addition to involvement in other compliance initiatives

Job Requirements:

  • Minimum of Bachelors Degree
  • Ten (10) plus years of relevant GxP pharmaceutical/biotechnology industry experience, including minimum four (4) to six (6) years of Compliance related or auditing experience (or equivalent)
  • Advanced subject matter expert in the required technical knowledge and expertise.
  • Ability to analyze emerging compliance issues and recommend strategies to manage compliance risks.
  • Travel: Position requires about 25% domestic and international travel.


To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying, please upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Apply for this job: GVP Compliance Audit Senior Manager

Contact Information:

Address:  ProClinical Ltd
Eldon House Eldon Street London
EC2M 7LS
England
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

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