Associate Director, Marketed Product Maintenance
5 mesi fa
PURPOSE
Direct, oversee and manage pharmacovigilance agreements and other designated processes for assigned customers. Oversee the production of PSMFs and provision of ad-hoc regulatory advice. Act as EU QPPV for clients with complex PV systems.
RESPONSIBILITIES- Serve as an advisor on safety agreements or other designated processes and provide expert review and guidance for production of safety agreement deliverables- May assist in the development and negotiation of safety agreements- Key customer interface for assigned customers, ensuring consistency in approach, metric and format and serve as an escalation point to resolve any issues- Ensure team follow global processes to deliver a quality product to customers- Develop and implement processes with a primary focus on increasing Customer satisfaction and by creating efficiencies while maintaining consistency among all teams.- Provide direction and strategy on projects and initiatives with mínimal oversight.- Maintain a focus and actively work towards attainment of all corporate goals (including but not limited to revenue, sales, and employee retention) and implement strategies to achieve those goals.- Participate in bid defense, customer meetings and on task forces as required- Act as primary internal customer interface, developing relationships- Provide advice, support and guidance as needed and serve as a mentor to colleagues- May assume the responsibilities of EU QPPV or deputy QPPV.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES- Bachelor's degree or educational equivalent in health science or other directly related field and 8 years' clinical research experience in a Contract Research Organization or Pharmaceutical company combining 5 years of Lifecycle Safety experience(Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management, etc) and 3 years' line management experience or equivalent combination of education, training or experience.- Very good knowledge of English and Italian language- In-depth knowledge of Lifecycle Safety service lines.- Proven staff management skills.- Excellent project management and communication skills.- Strong leadership, motivational and influencing skills.- Ability to work on multiple projects and manage competing priorities effectively.- Effective mentoring and developed coaching skills.- Strong judgment, independent thinking, decision-making and problem solving skills.- Ability to establish and maintain effective working relationships with co-workers, managers and clients.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at
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Milano, Italia IQVIA A tempo pieno**PURPOSE**: **Direct, oversee and manage pharmacovigilance agreements and other designated processes for assigned customers. Oversee the production of PSMFs and provision of ad-hoc regulatory advice. Act as EU QPPV for clients with complex PV systems.**: **RESPONSIBILITIES**: - **Serve as an advisor on safety agreements or other designated processes and...
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