We are looking to hire a European Union (EU) / United Kingdom (UK) Qualified Person for Pharmacovigilance (QPPV), based within an EU Member State.
The successful candidate will fulfill the role of the EU/UK QPPV and/or Deputy EU/UK QPPV for selected PPD clients.
The responsibilities include:
• Fulfillment of EU/UK QPPV and/or Deputy EU/UK QPPV role for selected PPD clients in accordance with EU Directive 2001/83/EC / UK Statutory Instrument 2012/1916 (both as amended), associated EU/UK regulatory guidance and applicable PPD procedures.
• Ensuring that EU/UK QPPV services are delivered in accordance with PPD policies and procedures and contractual agreements.
• Contributing to scientific safety services, such as safety writing, signal detection and/or literature surveillance.
• Overseeing and supporting the activities of pharmacovigilance contact persons at a national level.
• Promotion of good practices within PPD’s pharmacovigilance department, including through engagement in process improvement activities and delivery of training.
• Input into development of client proposals, and presenting at business development meetings to promote pharmacovigilance services to potential clients.
• Management of scope of work, budget oversight and resourcing for both new and existing EU/UK QPPV services clients.
The successful candidate will have a Life Sciences degree or higher degree and have extensive experience in senior pharmacovigilance roles, including the EU QPPV role, particularly:
• Expert knowledge of the EU regulations pertaining to pharmacovigilance
• Proven ability to establish processes and procedures and oversee effective pharmacovigilance systems
• Experience with pharmacovigilance inspections and audits
• Proven ability to manage stakeholders and to exercise creativity and judgement
• Excellent organization, project management, scientific writing and interpersonal skills
The position will give you the opportunity to develop in a highly-specialized and demanding sphere where you can apply your pharmacovigilance and regulations knowledge in a client-facing role.
To apply, please send your CV in English.