At Clinigen, we're 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 Person 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.
Requirements
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.
