Pharmacovigilance Quality Assurance Director, Open to flexible working
7 days left
- Contract Type
The purpose of this role is to:
Maintain a Pharmacovigilance quality assurance programme to ensure that the pharmacovigilance system supporting VH products is compliant with pharmacovigilance legislation and company policies and procedures.
Reporting into the Director, Pharmacovigilance and Regulatory Affairs Quality Assurance:
- Provide assurance to VH that processes for managing safety data are effective in ensuring the integrity of data, compliance with VH policies and procedures, and regulatory requirements and protection of patients
- Educate and engage VH senior management to understand key risk areas and PV universe, identify key quality and compliance risks and acquire agreement on remedial plans to address these risks
- Manage the VH PV QA programme including involvement in:
- Audit risk assessment of the VH PV audit universe
- Planning and scoping of audits identified in audit risk assessment
- Overseeing independent audits of PV activities to assure compliance with PV regulations, GSK and VH policies/procedures, and applicable local regulations
- Tracking PV CAPAs from VH initiated audits to resolution and verify effectiveness, monitor GSK CAPAs and escalate issues to EU QPPV, VH VP, Safety & PV.
- Ensure VH staff are prepared and supported during internal audits
- Oversight of audit outputs from GSK GQA as they impact VH products
- Maintenance of knowledge of Service Provider PV model to ensure that risks to VH products are identified and addressed through audit or other activities
- Inspection management for PV related aspects of GCP inspections and post-marketing PV inspections. Ensure all staff required to support inspections are sufficiently prepared.
- Collaboration with VH personnel to ensure that deviations and exemptions from VH written standards are led and detailed in alignment with regulatory requirements.
- Maintenance of audit and deviation data on the VH Pharmacovigilance System Master File
- Generate and provide metrics, status and periodic reports and other information to monitor the performance of PV QMS.
- Provide appropriate input relating to the risks associated with the PV Quality management system into VH governance and oversight meetings and meetings with Service Provider
- Provide expert advice in relation to compliance, quality improvement, process and program initiatives and risk assessment, and act as point of contact for customers
- Assist in the development of the existing QMS which underpins VH PV activities to ensure system and processes are in alignment with legislative requirements
- Maintain an up-to-date and in-depth knowledge of appropriate national and international PV/GCP legislation and guidelines as well as VH/GSK procedures that affect the business and advise VH management (PV) of implications. Collaborate with VH management (PV), to interpret international regulations and guidelines and establish and monitor compliance for acceptable standards for PV activities
- Develop and maintain a network of contacts within VH and GSK quality and compliance groups as well as external resources.
- Assist in developing, supporting and maintaining customer training programmes and help deliver training within area of expertise
- In-depth knowledge of Pharmacovigilance and GCP Safety legislation
- Experience of audit risk assessment of a PV audit universe
- Leading the planning, conduct and reporting of complex audits
- In-depth knowledge of Quality Management Systems
- Management of regulatory inspections, interactions with regulatory inspectors
- Project management experience
- Interactions with senior management and experience of influencing at all levels
- Member of Research Quality Assurance or similar industry organisation
Preferred Level of Education
- Science Degree
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at ViiV Healthcare bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities.
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