Qualified Person for Pharmacovigilance (QPPV), 3 years fixed-term contract-148832

Company
PPD
Location
Europe, Middle East & Africa-Bulgaria-Sofia, Europ
Salary
On Application
Posted
21 Sep 2018
Closes
25 Jan 2019
Ref
148832
We are looking to hire a European Union (EU) Qualified Person for Pharmacovigilance (QPPV), based within a non-UK EU Member State (due to the United Kingdom’s future withdrawal from the European Union.) 
The position is a maternity cover.
The successful candidate will fulfil the role of the EU QPPV and/or Deputy EU QPPV for selected PPD clients.  
The responsibilities include: 
•Fulfillment of EU QPPV and/or Deputy EU QPPV role for selected PPD clients in accordance with EU Directive 2001/83/EC, associated EU regulatory guidance and applicable PPD procedures. •Ensuring that EU 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 QPPV services clients.

Qualifications

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 IndeedPPDEMEA1

Similar jobs

Similar jobs