PV QA Manager
Posted 1 day ago by Hyper Recruitment Solutions
Negotiable
Inside
Remote
United Kingdom
Summary: The PV QA Manager role involves overseeing Pharmacovigilance Quality Assurance activities for a leading Pharmaceutical company in the UK, with a focus on ensuring compliance and excellence in safety information reporting. This position is remote and classified as inside IR35, requiring a relevant degree and proven experience in clinical or pharmacovigilance QA. The role includes executing audit programs, providing GPvP advice, and managing quality issues. The contract is for an initial duration of 12 months.
Key Responsibilities:
- Execute regional, cross-regional, and global audit programs, including planning, conducting, and reporting audits.
- Liaise with customers on audit findings.
- Provide expert GPvP advice to key personnel, including coaching QA colleagues.
- Interpret health authorities' requirements for implementation.
- Support the development and maintenance of the Quality System by addressing non-conformances.
- Manage quality issues related to critical non-conformities.
- Develop and manage interfaces with QA departments of service providers to ensure oversight and mitigate risks.
Key Skills:
- Relevant degree in a related field.
- Proven industry experience in clinical/Pharmacovigilance QA or the pharmacovigilance function.
- Working knowledge and practical experience with QA Standards, particularly Good Clinical and GPvP Practice Guidelines and Regulations.
Salary (Rate): undetermined
City: undetermined
Country: United Kingdom
Working Arrangements: remote
IR35 Status: inside IR35
Seniority Level: undetermined
Industry: Other
We are recruiting a PV QA Manager to join a leading Pharmaceutical company in the UK on a remote basis. This role is inside IR35 and is pivotal in ensuring excellence in Pharmacovigilance Quality Assurance (PVQA) activities. As the QA Manager, you will play a crucial role in supporting the PV system and the collection and reporting of safety information This is an initial 12 month contract and offers fully remote working. Please note you must have the full right to work in the UK.
Key Duties And Responsibilities
Your duties as the QA Manager will be varied however the key duties and responsibilities are as follows:
- As the QA Manager, you will execute regional, cross-regional, and global audit programs, including planning, conducting, and reporting audits, and liaising with customers on audit findings.
- As the QA Manager, you will provide expert GPvP advice to key personnel, including coaching QA colleagues and interpreting health authorities' requirements for implementation.
- As the QA Manager, you will support the development and maintenance of the Quality System by addressing non-conformances and managing quality issues related to critical non-conformities.
- As the QA Manager, you will develop and manage interfaces with QA departments of service providers to ensure oversight and mitigate risks to the business.
Role Requirements
To be successful in your application to this exciting role as the QA Manager, we are looking to identify the following on your profile and past history:
- Relevant degree in a related field.
- Proven industry experience in clinical/Pharmacovigilance QA or the pharmacovigilance function.
- A working knowledge and practical experience with QA Standards, particularly Good Clinical and GPvP Practice Guidelines and Regulations.
Key Words: QA Manager / Pharmacovigilance / PVQA / Quality Assurance / Clinical QA / GPvP / Audit Programs / Regulatory Compliance / Risk Management / Continuous Improvement / Clinical / Pharmaceutical / Biotechnology / Remote / PV / Veeva / eQMS
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.