Pharmacovigilance Quality Assurance Director, Open to flexible working

7 days left

Brentford (City/Town), London (Greater)
18 Nov 2020
03 Dec 2020
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.

Key Responsibilities

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

Basic Skills/Qualifications

  • 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. 

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Important notice to Employment businesses/ Agencies

ViiV Healthcare does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact ViiV Healthcare's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to ViiV Healthcare. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and ViiV Healthcare. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of ViiV Healthcare. ViiV Healthcare shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, ViiV Healthcare may be required to capture and report expenses ViiV Healthcare incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure ViiV Healthcare's compliance to all federal and state US Transparency requirements.