Gvp Consultant
4 weeks ago
Company Description
ADAMAS is a well-established, leading provider of mission-critical regulatory compliance and consulting services to the global pharmaceutical industry. It operates across Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Computer Systems Compliance (CSC) (together, GxP).
Founded in 2007, ADAMAS has focused on ensuring that the highest standards of best practice are attained across the pharmaceutical sector. ADAMAS has an established client base with an expansive global reach, including North America, Europe, and Asia Pacific. We work with over 100 currently active clients and have worked with over 700 pharmaceutical companies, including 40 of the 50 largest global pharma and biotech companies.
At ADAMAS, our people are our primary asset. We possess the highest and broadest level of in-house knowledge and can deliver genuine expertise and experience globally via in-house resources. ADAMAS's success is down to the calibre of its people - to reward them we offer a competitive salary with benefits, excellent working conditions and a fulfilling and rewarding career, with plenty of opportunities for further development.
**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
- Executing audits based on a comprehensive understanding of all regulatory requirements and Good Pharmacovigilance Practice (GVP)
- Performing GVP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry.
- Assist with business development activities
**Qualifications**:
- Experience in conducting and leading internal and external Pharmacovigilance audits for a variety of stakeholders
- Expert knowledge of national and international Pharmacovigilance legislation and guidelines
- Proficient in managing projects and ensuring deliverables are provided timeously
- Ability to identify issues and offer solutions in a pragmatic way
- Bachelor’s Degree in Life Sciences preferred
- Up to 40% travel and ability to conduct remote audits
Additional Information
Why ADAMAS?
As an organization, we prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why? Because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language
Our core values are key to how we operate, and if you feel they resonate with you then Adamas, an Ergomed Company is a great place to join
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
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