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Pharmacovigilance QA Advisor

Cambridgeshire   •  Permanent, Full time

Hyper Recruitment Solutions are currently looking for a Pharmacovigilance QA Advisor to join a leading company based in the Cambridgeshire area. As the Pharmacovigilance QA Advisor you will be responsible for ensuring all business areas are compliant with key regulatory guidelines and conducting PV QA audits within a Global Network.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Pharmacovigilance QA Advisor will be varied however the key duties and responsibilities are as follows:

1. Assist the Research Quality Team with audit planning and maintenance of a PV Audit Schedule, including ensuring all audits are fit for purpose and ensure maintained compliance. You will generate quality metrics and maintain and update department processes where required.

2. Perform PV audits of Internal and External Parties ensuring that the business remains compliant in accordance to regulatory guidelines. You will perform evaluations and audits of vendors due to conduct any PV related work within the business.

3. You will assist the business in preparing for regulatory inspections/audits as well as maintain subject matter expertise with any advances in PV Regulations/guidelines. This will inform the review/update of SOP's and documentation to ensure maintained compliance.

4. The Pharmacovigilance QA Advisor will implement effective CAPA's resulting from Audit findings to ensure continued compliance is maintained across the business. You will perform internal process audits to assess the robustness of internal processes to relevant PV legislation.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Pharmacovigilance QA Advisor we are looking to identify the following on your profile and past history:

1. Relevant degree in a Science related subject.

2. Proven industry experience in the Pharmaceutical industry within a Pharmacovigilance/Drug Safety related position.

3. A working knowledge and practical experience with PV Audits and improving compliance to regulations/legislations. Experience with implementing CAPA's in response to audit findings would be advantageous.

Key Words: PV | PSUR | CAPA | Compliance | Auditing | Pharmacovigilance

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.


You must be eligible to work in the UK. Learn more

  • Agency: Hyper Recruitment Solutions
  • Posted: 17th April 2018
  • Expires: 15th May 2018
  • Reference: J5223
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Contact

  • Recruiter: Chris Sowden
  • Phone: 0203 910 2980