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Qualified Person PVG

Pharmaceutical Product Development (PPD)

Multiple Locations

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.

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.LI-TK1

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.LI-TK1

Belgium, Romania, Portugal, Czech Republic, Switzerland, Bulgaria, Spain, Europe, Middle East & Africa, Ireland, Slovakia, Netherlands, Germany, Croatia, France, Hungary, Italy, Serbia, Poland, GreeceBelgium, Romania, Portugal, Czech Republic, Switzerland, Bulgaria, Spain, Europe, Middle East & Africa, Ireland, Slovakia, Netherlands, Germany, Croatia, France, Hungary, Italy, Serbia, Poland, Greece

Job posted: 2020-11-25

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