Job Reference: JO-2004-65164_1592222251
- 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.
- 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.
- 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.
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