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- Tasks: Join us as a freelance QPPV, ensuring patient safety and compliance in pharmacovigilance.
- Company: Clinigen is revolutionising healthcare with essential pharmaceuticals and services for patients worldwide.
- Benefits: Enjoy flexible work arrangements and the opportunity to collaborate on diverse projects.
- Why this job: Be part of a mission-driven team making a real impact on global health.
- Qualifications: 7+ years in pharmacovigilance, expert knowledge of regulations, and strong communication skills required.
- Other info: Work remotely from various EU locations and engage with cross-functional teams.
The predicted salary is between 60000 - 84000 £ per year.
At Clinigen, we are shaping the future of healthcare by delivering specialised pharmaceuticals and services that are essential for patients globally. Our dedicated team is comprised of ambitious and innovative professionals whose mission aligns with the larger goal of ensuring that the right medicine reaches the right patient at the right time. To support our continued growth, we are looking to build a network of freelance Qualified Persons for Pharmacovigilance (QPPV) for the EU and UK. As part of this flexible network, you will be called upon based on specific projects and workload requirements, providing support for various clients.
Key Responsibilities:
- Act as the Qualified Person for Pharmacovigilance and/or Local Contact Person for PV for the EU and UK, ensuring compliance with EU and UK pharmacovigilance legislation.
- Oversee pharmacovigilance activities, ensuring that all safety issues are identified, assessed, and managed appropriately.
- Ensure the timely submission of safety reports to regulatory authorities and maintain effective communication with stakeholders.
- Establish and maintain the pharmacovigilance system, including safety databases and processes for reporting adverse events.
- Work closely with cross-functional teams, including regulatory affairs, medical, and clinical operations to ensure compliance and to implement risk management plans.
- Provide guidance and support for safety-related matters for clinical trials and in the post-marketing settings.
- Support with audits and inspections to ensure compliance with internal procedures and regulations.
- Stay up to date with changes to pharmacovigilance legislation and guidelines and implement necessary changes throughout the organisation.
Skills and Experience Required:
- Experience in acting as a QPPV.
- Expert knowledge of PV legislation in territories where assigned as the QPPV.
- Minimum of at least 7 years' demonstrated experience in managing or implementing PV systems, including quality assurance experience.
- Documented experience in all aspects of PV in order to fulfil the responsibilities of QPPV.
- Extensive knowledge of global pharmacovigilance regulations and GVP and GCP guidelines.
- Experience in pharmacovigilance safety risk management including clinical trials, post-marketing pharmacovigilance, safety case processing, safety reporting, and safety system.
- Experience in participation in audits and Regulatory authority inspections.
- Life Science Degree; Medical degree is preferred; however not essential.
- Fluent in written and spoken English with strong verbal and written communication skills.
- Demonstrated ability to influence, work collaboratively within key stakeholders, effective communicator and analytical thinking ability.
- Extensive knowledge in MS Office Applications and Systems.
Freelance QPPV (EU and UK). Various EU Locations Considered. employer: Clinigen
Contact Detail:
Clinigen Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Freelance QPPV (EU and UK). Various EU Locations Considered.
✨Tip Number 1
Network with professionals in the pharmacovigilance field. Attend industry conferences, webinars, and local meetups to connect with potential colleagues and clients. Building relationships can lead to freelance opportunities and recommendations.
✨Tip Number 2
Stay updated on the latest EU and UK pharmacovigilance regulations. Subscribe to relevant newsletters or join professional organisations that focus on pharmacovigilance to ensure you are aware of any changes that may affect your role as a QPPV.
✨Tip Number 3
Showcase your expertise through online platforms. Consider writing articles or sharing insights on LinkedIn about pharmacovigilance trends and best practices. This can help establish you as a thought leader in the field and attract potential clients.
✨Tip Number 4
Prepare for interviews by familiarising yourself with Clinigen's mission and values. Understand their approach to pharmacovigilance and be ready to discuss how your experience aligns with their goals. Tailoring your conversation to their specific needs can make a strong impression.
We think you need these skills to ace Freelance QPPV (EU and UK). Various EU Locations Considered.
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities of a Freelance QPPV. Familiarise yourself with pharmacovigilance legislation in the EU and UK, as well as the specific requirements outlined in the job description.
Tailor Your CV: Craft your CV to highlight relevant experience in pharmacovigilance, particularly your role as a QPPV. Emphasise your knowledge of PV legislation, safety reporting, and any experience with audits and inspections.
Write a Compelling Cover Letter: In your cover letter, express your passion for healthcare and how your background aligns with Clinigen's mission. Mention specific projects or experiences that demonstrate your expertise in pharmacovigilance and your ability to work collaboratively with stakeholders.
Proofread Your Application: Before submitting, carefully proofread your application materials. Ensure there are no grammatical errors and that all information is clear and concise. A polished application reflects your attention to detail, which is crucial in this field.
How to prepare for a job interview at Clinigen
✨Know Your Pharmacovigilance Legislation
Make sure you have a solid understanding of EU and UK pharmacovigilance legislation. Be prepared to discuss how your experience aligns with these regulations and how you've ensured compliance in previous roles.
✨Showcase Your Experience
Highlight your extensive experience in managing or implementing pharmacovigilance systems. Be ready to provide specific examples of how you've handled safety issues, audits, and inspections in the past.
✨Demonstrate Cross-Functional Collaboration
Since the role involves working closely with various teams, prepare to discuss how you've effectively collaborated with regulatory affairs, medical, and clinical operations in your previous positions.
✨Stay Updated on Industry Changes
Show that you are proactive about staying informed on changes to pharmacovigilance legislation and guidelines. Discuss any recent updates you've implemented in your work to ensure compliance.
