This global innovator biopharmaceutical company discovers, develops and commercialises innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide and strives to innovate new products to meet these unmet diseases. In Ireland, this organisations operations are responsible for manufacturing, quality control, packaging, and the release and distribution of the company's products in the European Union and other international locations such as the countries supported by the organisation's Access Program. In recent times, the organisation have taken the decision to expand operations further in Dublin and developing a Centre of Excellence at their new offices in Dublin. As a result of this growth, a new requirement for a Director of PV Quality has arisen.
This organisation are looking for a Pharmacovigilance Compliance Director who is ready to join the businesses 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. Utilising expert Good Pharmacovigilance (GVP) and Good Clinical Practice (GCP) knowledge this role will be a trusted business partner effectively communicating and collaborating with senior stakeholders and leadership teams across the global organisation.
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 at the organisation's new location in Dublin.
- BSc 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.
- Strong verbal and written communication skills and interpersonal skills.
- Proficient in Microsoft Office suite. Experience with audit management/CAPA management programs strongly preferred.
To discover more about this opportunity, apply now or contact Shane Browne at HRM on +353 1 632 1865 for a confidential discussion.