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Freelance QPPV (EU and UK). Various EU Locations Considered.
Posted 24 days agoViewed
💎 Seniority level: Senior, 7+ years
📍 Location: France, Spain, Italy
🔍 Industry: Pharmacovigilance
🏢 Company: Clinigen👥 251-500PharmaceuticalIndustrialManufacturing
🗣️ Languages: English
⏳ Experience: 7+ years
Requirements:
- 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
- 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.
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.
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