GVP Consultant (PV Auditor) Job at Adamas Consulting
Company Description
ADAMAS Consulting has been leading the industry for over two decades, conducting audits in all therapeutic areas in over 100 countries. By applying critical thinking to solving compliance issues as pragmatically and efficiently as possible we continuously innovate to meet the challenges of the ever-changing clinical landscape.
Job Description
Responsibilities:
- 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), risk-based audit strategies, and regulatory compliance issues, and preparation and delivery of training material)
- Maintaining an up-to-date knowledge of international regulatory requirements, guidelines and best practices and actively participating in the ADAMAS’ knowledge-sharing and learning process
- Assist with business development activities
Qualifications
Additional Information
- 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 self-motivated
- Ability to travel up to 25%
Additional Information
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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