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Director, Pharmacovigilance Quality & Compliance (GVP)

Reference:KS/AJCP-615614 Location: Dublin
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed

Our client is a leading Global Biopharmaceutical organisation who play a crucial role in developing life-saving therapies. They are seeking a Pharmacovigilance Compliance Director who will join their Global R&D Quality and Compliance team. As a member of the global PV management team you will provide leadership in setting the strategic direction of Quality and Compliance PV activities.

This role is suited to candidates who possess strong leadership skills and strategic thinking. Utilizing expert Good Pharmacovigilance (GVP) and Good Clinical Practice (GCP) knowledge. The successful person will be a trusted business partner effectively communicating and collaborating with senior stakeholders and leadership teams across the global organization.

You will be a part of an expert team supporting global clinical development and post-marketing programs. This includes a special emphasis on pediatric trials, based in our clients new location in Dublin, Ireland.

Role/ Responsibilities:

  • Active member of the Global R&D Quality & Compliance PV management team
  • Manage the pharmacovigilance audit program based out of the Dublin office. This includes internal process, affiliate, distributor and external vendor audits.
  • Manage and/or lead diverse & specialized types of audits or projects involving multiple sites, commercial products and/or therapeutic areas.
  • Liaises with PVE management and other internal stakeholders to execute PV compliance activities on multiple commercial product Patient Assistance, Patient Support and Market Research programs, commercial product distributors, business partners and affiliates
  • Represent Regulatory Compliance in PV-related Working Groups as appropriate
  • Effective compliance reporting to senior management and relevant quality governance forums.
  • Investigate critical compliance Issues
  • Support CAPA development and perform effectiveness checks of CAPAs
  • Deliver end-to-end regulatory PV inspection strategy and management, which includes facilitation of regulatory agency PV inspections and partner audits, occurring both in-house and at affiliates.
  • Support regulatory agency inspections as needed
  • Fosters a commitment to quality in individuals and a culture of quality within the organization.
  • Provides expert, timely and risk-based guidance in line with regulations & business needs
  • Qualify, and establish agreements with contract auditors
  • Direct contract auditors and others who oversee activities performed by contract auditors.
  • Evaluate departmental and business area SOPs for fitness for purpose and for compliance with regulatory requirements
  • Provide Q&C input on new SOPs, often regarding complex processes entailing complicated cross-functional work and inter business partner relationships.
  • Ensure adherence to departmental SOPs across sites.
  • Lead intra or interdepartmental teams of an operational nature such as preparing the company for minor changes in regulations, continuous improvement initiatives.
  • Direct others in prioritizing their work.

Qualifications/ Experience:

  • BSc or MSc and 10+ years relevant experience
  • Must have significant GVP & GCP audit and compliance experience.
  • Bio-pharma sponsor or CRO experience required.
  • Recognized as an expert resource on a range of clinical compliance topics.
  • Strong verbal and written communication skills and interpersonal skills.
  • Proficient in Microsoft Office suite. Experience with audit management/CAPA management programs strongly preferred.
  • Excellent organization skills and project management.
  • Able to work equally well as part of a team or independently
  • Ability to travel approximately 25% required.

For further details please call Karen Shiel on 087 7452487 for a confidential discussion or send CV to