PV Specialist-PV QA Audit

Job Description:

Responsibilities

• Support the Global Head Pharmacovigilance Quality Assurance in defining the strategy for and establish a robust, integrated PV Quality Management System. 
• Drive the development, implementation and oversight of all quality aspects of the Pharmacovigilance Quality Management System (PV QMS). 
• To work closely with the Global Head of PV QA, Global Head of PV, and Regional/Functional Heads to help define PV QMS strategies and ensure the fulfilment of regulatory requirements.
• Act as a back-up/designee to Global Head PV QA, as required. 
• Support in the creation, revision and withdrawal of PV-related procedural documents. 
• Ensure PV processes have appropriate documentation and identify any process gaps. Maintain document review and life-cycle. 
• Review and provide input to PV documents as needed to ensure PV processes are adequately documented. 
• Provide QA support in the roll-out of IT tools in the Pharmacovigilance function. 
• Support in achieving a robust, inspection-ready quality management system for PV which meets internal quality standards and global regulatory requirements for PV quality. 
• Provide support for the conduct and management of regulatory authority inspections. 
• Support preparation efforts including training of personnel on inspection behavior and how to answer inspector questions, assist in the generation of story boards to cover key areas and to provide SME lists for interview. Manage the logistics for the inspection cnduct, including availability of rooms, scribe, and technology as required. 
• Support the Global Head Pharmacovigilance Quality Assurance in defining a risk based approach to the selection of affiliates and commercial partners (licensee partners, distributors, vendors) for audit. 
• Ensure routine, regular end to end audit of the PV system. 
• Support the conduct of third party audits of DRL as needed to ensure appropriate management of regulatory inspections for PV. 
• Support in fulfilling regulatory requirements for a full, systematic approach to auditing the PV system. 
• Work with the Global Head of PV and Global Head PV QA to establish a process for the tracking of self-identified, unplanned and planned deviations from PV processes. 
• Ensure that the streamlined process is established for escalation of overdue CAPA to ensure robust processes for deviation and CAPA management as a requirement of a functioning QMS. 
• To drive the development of cross-functional CAPAs, where the buy-in from other departments in addition to PV is needed to reach desired outcomes. 
• Support in identifying areas for development/process improvement to promote efficiencies. 
• Participate / contribute to organization wide initiatives and responses to new regulatory requirements. Maintain a contemporary knowledge of current industry trends, standards and methodologies as it relates to PV quality management. 

Qualification & Experience

• Graduation or Masters in any discipline. Science/Pharmacy/ Medicine
• Minimum Work Experience
• 8+ years experience within pharma industry.
• Skills & Attributes Functional Skills
• Broad knowledge of global regulations for pharmacovigilance, in particular ICH guidelines, FDA, EMA and Good Vigilance Practices (GVP) guidelines. 
• Demonstrates expertise related to understanding the principles and application of quality and regulatory compliance. 
• Demonstrates leadership within cross-functional team environment. 
• Excellent teamwork and interpersonal skills. 
• Demonstrates ability to effectively communicate and influence the outcomes of the decision-making process. 
• Strong negotiation skills encouraging discussion and driving decisions to desired results. 
• Fluent in English (written and spoken)