PV Auditor (Contract / N. America sites)

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

• The GVP Auditor will be subject matter lead for clinical consulting and auditing projects within ProPharma Group.

• Execute audits based on experience and a comprehensive understanding of all federal regulatory requirements and ICH (International Council for Harmonization) guidance on Good Clinical Practice (GCP) and guidance on Good Pharmacovigilance Practices (GVP).

• The GVP Auditor will be a critical team member who contributes to the implementation of a risk based GVP audit program and provides oversight / management of the GVP consulting program.

• Promote continual improvement regarding customer satisfaction with emphasis on GVP consulting services.

• Keep pace with advances and technological changes in clinical support Services within the pharmaceutical / device / biotech industries and promote those that will increase the company’s effectiveness and profits.

• Provide support to clients and all functional units of ProPharma Group as clinical compliance issues such as deviations and non-conformances arise. Provides consultation for the implementation of proper CAPA to resolve deviations and non-conformances.  Also, is responsible for helping to ensure compliance of company operations to quality principles and participation in the development of quality systems through SOP writing and training.

• The GVP Auditor is responsible for promoting GVP subject expertise through publications and presentations through professional networks.

• The GVP Auditor will provide ongoing support and expertise to all personnel, assisting them in establishing goals, objectives, policies, and procedures for all applicable subsets of this business unit within the company.

• Help to ensure the consulting practices are in compliance with all applicable internal and external policies procedures, and industry best practices.

• Generation of proposals for GVP auditing and clinical-related projects.

• Assist Operations in staffing client projects to enable the company to execute the strategic plan efficiently and effectively, and to meet revenue and profit goals based on personnel skills development and client needs.  Includes candidate interviewing skills.

• Audit GVP projects for correct approach, consistency, and quality.

• Ability to interact in a professional and positive manner with clients and co-workers.

• Ability to organize and manage projects.

• Quality orientation and high attention to detail.

• The role will guarantee the continued success of the company by ensuring that all employees, contractors, and the company as a whole meet or exceed established quality and compliance guidelines.

• Strong working knowledge of international cGVP requirements and standards.

• Utilize expertise of quality systems, data integrity, software compliance and GVP requirements to conduct audits and provide Gap analyses and risk assessments for clients.

• Perform Customer Service functions in response to client inquiries.

• Strong editorial skills for the review and approval of GxP documentation, including protocols, reports, SOPs, etc.

• Effective written and oral communication skills; ability to write, type, express or exchange ideas by means of the spoken word; convey information/instructions accurately; receive detailed information through oral or written forms and to translate those instructions into physical execution of tasks.

• Ability to manage and mentor colleagues in company GVP and Clinical compliance-related activities.