See All Jobs

Executive / Management

Job Description

A Director of Pharmacovigilance and Compliance is required to join our Dublin clients Global R&D Quality and Compliance team. Please contact Diarmuid Buckley for full details.

Role of this position

  • 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 & specialised 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
  • Investigate critical compliance Issues
  • 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.

JOB REQUIREMENTS

  • BA or BS and 10-12+ years of relevant experience (10+ years of relevant experience with an MS).
  • Must have significant GVP & GCP audit and compliance experience.
  • Bio-pharma sponsor or CRO experience required.
  • Recognised as an expert resource on a range of clinical compliance topics.
  • Ability to travel approximately 25% required.

Please call Diarmuid Buckley today for further information on 021- 4355432 or email: dbuckley@careerwise.ie
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

Apply Now

Executive / Management

Cork Office

CareerWise Recruitment. EastGate Village, EastGate, Little Island, Cork.

Phone: +353 (0) 21 206 1900

Email: info@careerwise.ie