Gvp Consultant
7 days ago
Job Description:
- Planning, preparation, conduct, reporting, and follow up (including CAPA plans) of various types of Pharmacovigilance (PV) audits according to expected quality and timelines
- Delivery of consultancy services (e.g., providing advice to clients and developing Standard Operating Procedures (SOPs), Quality Management System (QMS), riskbased audit strategies, and regulatory compliance issues, and preparation and delivery of training material)
- Maintaining an uptodate knowledge of international regulatory requirements, guidelines and best practices and actively participating in the ADAMAS' knowledgesharing and learning process
- Assist with business development activities
Qualifications:
- BSc in Life Science or Nursing
- Significant experience in leading and conducting internal and external PV audits for a variety of stakeholders
- Expert knowledge of applicable PV regulations and guidance
- Proficient in managing projects and ensuring deliverables are provided in a timely manner and to high quality standards
- Ability to identify issues and offer solutions in a pragmatic way
- Highly professional and selfmotivated
- Ability to travel up to 30%
Our people and the way we work set us apart.
We work closely with our clients, providing industry-leading innovation and knowledge to deliver solutions that add genuine value to their business.
We place great worth on development and collaboration so we can best succeed together. When needed we also place great importance on intellectual curiosity and the ability to work autonomously.-
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