PV Case Processing Lead Recordati Rare Diseases

Recordati, established in 1926, is an international pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271), with a total staff of more than 4,300, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. Headquartered in Milan, Italy, Recordati has operations in Europe, Russia and the other C.I.S. countries, Ukraine, Turkey, North Africa, the United States of America, Canada, Mexico, some South American countries, Japan and Australia. An efficient field force of medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in several therapeutic areas including a specialized business dedicated to treatments for rare diseases. Recordati is a partner of choice for new product licenses for its territories. Recordati is committed to the research and development of new specialties with a focus on treatments for rare diseases.
Role Overview

• Reporting into the Head of Global PV Rare Diseases, the PV Case Processing Lead will conduct and oversee PV operations for Recordati Rare Diseases (RRD) PV Group,. Role is responsible for:-
• Management and delivery of the pharmacovigilance function
• Oversight & Management of all outsourced activities to the vendor dealing with PV operations
• data management (triage, case processing, coding conventions, distribution, submission, reconciliation and literature screening
• Database contact point (Coordination/ liaison) and supervise LL extraction.
• Vendor Management set up, oversight & performance KPI covering PV activities case processing, submission, distribution, reconciliations, literature screening
• To prepare and maintain all documentation and SOPs as required for the management of Pharmacovigilance Operations activities within the organisation, and PV vendor
• Support PV System with appropriate process, documentation and KPI for all PV matters relative to data management
• Establish a proper periodic quality control of cases and CAPA where appropriate
• Acts as the key contact during inspection for all PV Operations for data management
• To lead the delivery of pharmacovigilance operations across the business through the team and in collaboration with functions (others groups in RRD PV, in Patient safety groups, R&D, Clinical Regulatory, QA, Legal) with support of a team member
• To ensure sufficient knowledge on the safety database to ease communication with Patient Safety group , appreciate impact of changes on RRD products, line listing production, contribute to database improvement
• Act as a key member of the management group to develop, contribute and drive delivery and focus across the business in line with the company objectives
  

Key Skills And Experience

• 3 >5 years of experience in PV CRO management
• Management experience
• Rigorous, open-minded focus on objective pragmatic approach
  

At Recordati, we believe in equal opportunities, and we guarantee that everyone can achieve their potential. We see diversity as a value and will not tolerate any discrimination based on ethnicity, nationality, gender, sexual orientation, disability, age, political or religious belief, or any other personal characteristics. At Recordati, we work hard to create a safe and inclusive work environment, where we all have our rights to physical and psychological integrity respected on a daily basis, as well as our right to freedom of opinion and association. We recognise that we each have a role to play in the success of our business and we implement staff development policies through which everyone’s contribution and achievements can be appropriately rewarded.