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.
- 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: firstname.lastname@example.org
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