Pharmacovigilance QA / Compliance Officer

Location
Berkshire
Salary
Competitive
Posted
21 Jul 2017
Closes
18 Aug 2017
Ref
J4186
Contact
Chris Sowden
Contract Type
Permanent
Hours
Full Time
Hyper Recruitment Solutions are currently looking for a Pharmacovigilance QA/Compliance Officer to join a leading Pharmaceutical company based in the Berkshire area. As the Pharmacovigilance QA/Compliance Officer you will take responsibility for Quality and Compliance activities related to Pharmacovigilance for all company products.

KEY DUTIES AND RESPONSIBILITIES:

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

1. Maintain expertise of local/international regulations (GVP/GCP) relative to Pharmacovigilance and Quality, supporting the PV Manager in developing and implementing a QA PV strategy and associated QMS system.

2. The Pharmacovigilance QA/Compliance officer will support the update of all quality related sections of the Pharmacovigilance system master file (PSMF) as well as reviewing and developing internal and external SOP's.

3. You will develop and implement strategic audit plans for Pharmacovigilance activities concerning the company and related third parties, you will engage with vendors writing requests for proposals (RFP's) or work orders/ Pharmacovigilance agreements to manage third parties acting on behalf of the company.

4. You will lead internal and external pharmacovigilance audits, overseeing and engaging with third parties, you will present QA findings/observations to in house staff evaluate CAPA's and implement continuous improvement projects from audit findings.

5. It will be your responsibility to escalate quality events to senior RDQA management, identifying root causes for investigations and provide training on GVP principles to your colleagues. You will be a representative for the PV QA team in inter-department meetings.

ROLE REQUIREMENTS:

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

1. Relevant degree in a life science degree or equivalent

2. Proven industry experience in a Pharmacovigilance/Compliance function with knowledge of GVP, GCP, GDP and GLP guidelines.

3. A working knowledge and practical experience with EU Pharmacovigilance guidelines in a R&D / Commercial products environment would be advantageous.

Key Words: Pharmacovigilance | GVP | GCP | GLP | GDP | EU Pharmacovigilance | QA | Quality Assurance | Compliance | PV | SOP's | PSUR's | Pharmacovigilance Site Master File (PSMF) | Audit | Internal Audit | External Audit | Vendors | Third Parties | New Products | Development | MHRA | CAPA | Inspection | Self-inspection | PV QA |

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.