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Marketed Prod Safety Spec 2
Egypt
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 https://jobs.iqvia.com
IQVIA Safety Operations team play an important part in the design, build and execution of end-to-end safety solutions for major pharmaceutical companies and their post market products around the world. We are proud to be an international, diverse team based across the world, with ‘safety hubs’ in Ireland, Poland, Austria, Portugal, Slovakia, Spain, India and USA. Each new joiner is supported by a nurturing management team, collaborative colleagues as well as a clear career ladder with plenty of opportunities to allow you to grow, adapt and shine.
Apply knowledge and expertise including complex decision-making activities to review, assess and process Safety data and information across service lines. Recognized as specialist in one or more areas. Provide oversight on small to medium service operational projects and act as mentor to junior members of staff.
Key Responsibilities:
Develop and prepare pharmacovigilance agreements for assigned customers. Prepare pharmacovigilance systems master files under direct supervision. Act as deputy EU- QPPV.
Essential Functions
- Work closely with project teams to determine appropriate terms and conditions of safety agreements.
- Develop and prepare safety agreements.
- Prepare and maintain PSMFs.
- Review PSMFs prepared by other specialists. Primary customer interface on large, complex projects, responsible for developing and maintaining customer. relationships.
- Provide input to project plans to accurately reflect services provided.
- Oversee finalization and distribution of safety agreements.
- Assist in the negotiation of safety agreement text using approved processes and templates.
- Represent safety agreements team at customer meetings as required.
- Provide input into project budgets involving safety agreements.
- Provide advice, support and guidance to other staff involved in preparing safety agreements.
- Mentor and train team members.
- Perform all other duties as assigned
Required Skills and Qualifications:
- Bachelor's Degree Preferably in health science or related area Req
- 3 years' experience of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, safety Publishing, Risk Management etc) with project management experience. Equivalent combination of education, training or experience.
- Excellent knowledge of Lifecycle Safety processes.
- Excellent attention to detail and accuracy and maintain consistently high quality standards.
- Excellent written and verbal communication skills.
- Ability to work effectively on multiple projects simultaneously.
- Organize own workload and effectively time manage competing priorities.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
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