Freelance Qualified Person for Pharmacovigilance (QPPV) in the EU and UK.
Clinigen is shaping the future of global healthcare by providing vital pharmaceuticals and services to patients worldwide. Our dedicated team consists of ambitious and innovative professionals driven to ensure that the right medicine reaches the right patient at the right time.
To support our continued growth, we are seeking a network of freelance Qualified Persons for Pharmacovigilance (QPPVs) for the EU and UK. As part of this flexible network, you will be assigned to projects based on specific requirements, providing expertise to various clients.
Main Responsibilities:
* As QPPV or Local Contact Person for PV in the EU and UK, ensure compliance with EU and UK pharmacovigilance legislation, regulations, and guidelines.
* Oversee all pharmacovigilance activities to identify, assess, and manage safety issues appropriately.
* Ensure timely submission of safety reports to regulatory authorities and maintain effective communication with stakeholders.
* Establish and maintain a robust pharmacovigilance system, including safety databases and processes for reporting adverse events.
* Collaborate closely with cross-functional teams, including regulatory affairs, medical, and clinical operations, to ensure compliance and implement risk management plans.
* Provide guidance and support on safety-related matters in clinical trials and post-marketing settings.
* Support audits and inspections to ensure adherence to internal procedures and regulations.
* Stay up-to-date with changes to pharmacovigilance legislation and guidelines, implementing necessary adjustments throughout the organisation.
Requirements:
* Experience as a QPPV, with proven track record.
* Expert knowledge of pharmacovigilance legislation in territories where assigned as the QPPV.
* A minimum of 7 years' experience in managing or implementing pharmacovigilance systems, including quality assurance.
* Demonstrated expertise in all aspects of pharmacovigilance to fulfill the responsibilities of a QPPV.
* Extensive knowledge of global pharmacovigilance regulations, including GVP and GCP guidelines.
* Experience in pharmacovigilance safety risk management, including clinical trials, post-marketing pharmacovigilance, safety case processing, safety reporting, and safety system management.
* Participation in audits and Regulatory authority inspections.
* Life Science degree; a Medical degree is preferred but not essential.
* Fluent written and spoken English, with strong verbal and written communication skills.
* Ability to influence, work collaboratively within key stakeholders, and demonstrate effective communication and analytical thinking.
* Proficiency in MS Office Applications and Systems.