Pharmacovigilance Quality Assurance Lead

Pharmacovigilance Quality Assurance Lead

Requirements

• Bachelor’s Degree or equivalent in biology, animal science or other relevant science field.
• Demonstrated relevant auditing experience (minimum 5 years) in veterinary pharmacovigilance or related regulatory environment.
• Experience with deviation/CAPA processes and associated documentation.
• Experience in managing people.
• High level of competency using Microsoft Office suite (e.g., Word, Excel, Outlook).
• Establishment of excellent interpersonal relations; good communications; ability to negotiate, risk assess, and problem-solve.
• Ability to work independently, while fostering good working relationships across physical distance and have flexibility and the capacity to handle multiple tasks at once.
• Ability to travel, if needed.

Responsibilities

• Oversee the Quality Assurance (QA) PV program for Zoetis.
• Continuously develop and drive the strategy for quality and regulatory compliance within the program.
• Provide quality assurance oversight to the global PV program.
• Be the point of contact for pharmacovigilance QA, ensuring alignment and open communication with US and European Pharmacovigilance teams and other stakeholders of the program.
• Lead the day-to-day GQC PV operational activities including the scheduling of GQC PV auditing activities (process audits, distributor and Zoetis Country Office audits).
• Be proficient in performing pharmacovigilance quality assurance audits and inspections of Veterinary Medicine Research & Development (VMRD) PV processes as well as those PV processes which reside outside the VMRD organization (e.g., country offices, distributors).
• Take a lead QA role in the management of CAPA and deviation activities for pharmacovigilance operations.
• Participate in government inspections of the pharmacovigilance program and others types of inspections as requested.
• Provide advice on regulatory and corporate compliance, as well as provide evaluations of current practices that may need improvements.
• Provide novel approaches to increasing effectiveness of both the GQC group and the quality and compliance of VMRD.
• Interact effectively with VMRD managers and their staff as an advisor on the interpretation of compliance aspects.
• Supervise GQC colleagues and contractors who participate in PV audits.
• Be responsible for meeting company driven deadlines for conducting performance evaluations, colleague development planning, and other required supervisory roles.
• Assist the GQC Global Lead with budgetary planning and monitoring activities.
• Where appropriate, assist with staff recruitment and training.
• Participate in a variety of quality assurance-related activities including staff and project meetings, non-research study document reviews, and consultations with VMRD colleagues.
• Take a lead role in participating in VMRD meetings, specifically GQC PV meetings, projects and *ad hoc* committees for quality initiatives.
• Communicate (verbal and written) well with VMRD colleagues, management level individuals, and external parties (e.g., distributors, CROs, vendors).
• Ability to effectively represent the company or the GQC group in external-facing situations.

Preferred Qualifications

• Master’s degree or equivalent in biology, animal science or other relevant science field.
• 10+ years working in a research quality assurance field supporting animal health trials.
• 5+ years in managing people.
• Experience in conducting pharmacovigilance audits and participating in regulatory inspections.
• Experience in working with pharmacovigilance databases.
• Proficiency in the understanding of current regulatory requirements regarding the quality of research for registration of animal products in major global markets.
• Proficiency in performing quality assurance audits and inspections of non-clinical and clinical veterinary product studies and reports (including protocols, data/data listings, statistics, master study files, final study reports, clinical investigator study sites and in-phase inspections) and of facilities, CROs and processes that support those studies.