For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
We are currently looking to partner with an Freelance Senior GCP/GVP Consultant based in Sweden for a small project supporting one of our leading Pharmaceutical clients. This project is to run from April/May; will last at least until the end of 2023 (8-9 month project) for 4 hours per week. The initial handover of the role would require minimal travel around the Stockholm region but the role is primarily remote based.
Responsibilities include
Participation and responses to GCP and PV audits
Conduct Audits as and when needed
Update our clients QMS and GCP SOPs
Conduct GCP Refresher training
Conduct GCP Regulatory Surveillance activities
Quality Management Team meeting Support
Qualifications
Educated to at least a BSc level within a life-sciences discipline
Can demonstrate key experience working in GCP Quality
GVP exposure is also required
Demonstrated experience conducting audits
Fluency in English and ideally Swedish
Strong stakeholder management skills
Thorough understanding of key regulations
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
ProPharma Group is the leading global, independent, single-source provider of regulatory, clinical, and compliance services serving the pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio... Read More
