PHARMACOVIGILANCE MANAGER - Italy
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- We are a service provider Company, leader in Pharmaceutical and Medical Device sectors since 1998 with a network of over 300 dedicated consultants.
- We deliver the highest level of expertise to more than 160 customers worldwide.
- Due to a constant growth, we are looking for a Pharmacovigilance Manager.
Responsibilities include, but are not limited to, the following:
- Develops pharmacovigilance audit plans and performs audits
- Manages quality event reports and corrective action and preventative action (CAPA) plans
- Administers, collects, and regularly report performance assessments related to pharmacovigilance processes
- Provides pharmacovigilance representation during QA/PV team meetings and other cross-functional initiatives related to quality, standards, and training
- Support audit and regulatory inspection activities of pharmacovigilance systems
- Manages and ensures product complaints with adverse events are processed in accordance with company standards and worldwide guidelines and evaluates product complaint trends for potential patient safety concerns
- Regularly provides PV compliance and performance metrics
- Manages, coordinates, and supports updating of the Pharmacovigilance System Master File
- Provides pharmacovigilance training
- A minimum of a Bachelor of Science (BSc) degree (or equivalent degree) in a life science, natural science or business is required
- A minimum of 10 years’ experience in an applicable compliance field and/or the equivalent time and training/experience in a related R&D area (GxP regulated discipline) is required
- A minimum of 5 years’ experience and demonstrated leadership in a quality function is highly preferred
- Knowledge of the global drug development process, including current GxP compliance regulations (national and international), scientific terminology, company quality assurance procedures and policies, and quality auditing and evaluation techniques is required
- Ability to apply strategic vision to develop and implement new quality assurance policies and procedures, and provide input to business policies and procedures is required
- Strong personal leadership with demonstrated competency interfacing with senior leaders is required
- Proven track record of directly leading leaders and managers in a global quality & compliance environment is highly preferred
- Knowledge of auditing and CAPA related tools or systems is required
- Full availability to travel
- Our collaborators are engaged, developed, challenged and well-rewarded for performance.
- We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.