Director, Pharmacovigilance Quality Assurance

Proclinical is seeking a Director, pharmacovigilance Quality Assurance to be based in the Cambridge area on a permanent basis. The Director, GVP Quality Assurance, is responsible for establishing the vision and implementing the associated strategy for the Pharmacovigilance (PV) Quality Assurance (QA) function. The Director, GVP Quality Assurance will ensure Good Pharmacovigilance Practice (GVP) within the company throughout all phases of the product development life cycle, including pre-clinical, clinical and post-marketing stages globally.

Job Responsibitlies:

• Ensure PV audits are scheduled, conducted and reported as planned
• Ensure PV audit CAPAs are established, agreed and tracked to closure
• Ensure PV audit metrics are prepared, analysed and improvements instituted
• Manage activities of subject matter experts and support staff during inspections
• Ensure timely responses to inspection findings are prepared, submitted and associated CAPAs tracked to closure
• Provide input into applicable new PV vendor contracts
• Review training presentations, training records and training compliance reports
• Participate in planning, oversight and conduct of PV training, as required
• Oversee deviations impacting on PV:
• Identify and monitor deviations impacting on PV
• Ensure CAPA resolutions are established
• Verify effectiveness of the CAPA resolutions
• Assist risk assessment implementation within PV and QA processes
• Identify strategies to enhance GVP compliance and PV QA efficiencies
• Provide critical review and approval of PV department policies/procedures/work instructions
• Support periodic assessment of PV department policies/procedures/work instructions
• Provide critical review of quality systems procedures from a PV QA compliance perspective
• Write or update PV-focused QA departmental procedures
• Provide critical review of PV department documentation, including vendor oversight management plans, business continuity plans, disaster recovery and other operational documentation, as needed
• Participate in PV and QA department computer system selection and implementation, including review and approval or execution of protocols, scripts and reports, as assigned

Skills & Requirements

• Regulatory Knowledge - Expert knowledge of global GVP regulations and guidances. Understands the regulatory environment for global pharmaceutical companies, as well as best practices to satisfy regulatory requirements. Successful interactions with regulatory authorities, including the FDA, EMA, ANVISA, etc.
• Industry Knowledge - Strong working knowledge of the pharmaceutical industry and the new drug development process. Understands the phases, processes and techniques used to execute a clinical development program. Understands the unique business requirements of operating as a marketing authorization holder in a virtual pharmaceutical environment.
• Functional Knowledge - Expert knowledge of and experience in quality assurance, auditing, inspection support, procedural management and quality systems (including training, deviations, corrective and preventive actions, risk management) as implemented within GVP. Track record of resolving complex GVP quality and compliance issues. Solid knowledge of the application of information technology within PV and specifically PV database systems such as Argus. General awareness of GCP, GMP and GDP activities.
• Communication Skills - Must professionally, clearly, concisely and consistently communicate to internal and external colleagues at all levels, both verbally and in writing. Must demonstrate effective presentation and training skills. Must demonstrate effective negotiation and conflict resolutions skills.
• Organizational / Project Management Skills - Takes initiative and works independently. Demonstrates proficiency in managing complex projects, delivering expected deliverables in a timely manner, and proactively communicating changes in established goals and deadlines. Must prioritize work effectively to meet timelines.
• Interpersonal Skills - Must be able to adapt to other personalities in a respectful manner that is conducive to goal achievement and team building.
• Computer Skills - Must be able to efficiently plan, manage, conduct and track deliverables and to communicate with internal and external colleagues using the provided computer.
• Personnel Management - Proficient in managing, coaching and mentoring staff. Effective in delegation to staff.
• A minimum of 15 years of relevant and increasingly responsible experience in the Biotech/ Pharmaceutical Industry, specifically within GVP and with at least 10 years in quality or compliance.
• Extensive experience in GVP auditing and managing regulatory authority inspections is required.
• Bachelor's or master's degree in a scientific or life sciences discipline. A healthcare background is preferred.
• Minimum of 7 years direct management experience.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kevin Hansberry on +44 207 4400 636 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.