Our client, a leading global pharmaceutical company that is headquartered in Japan, is seeking a QPPV Office Scientist to join their team in Herfordshire, UK. The company is dedicated to developing therapies in the areas of oncology and neurology, that will significantly impact patients' lives. This is a permanent position.
This QPPV Office Scientist job will provide management of information to help ensure the maintenance of the pharmacovigilance system and to facilitate QPPV oversight, including:
- Management of company Pharmacovigilance System Master File (PSMF)
- Ensure appropriate processes, resources and communication mechanisms to enable the EU QPPV full oversight of structure and performance of the company Pharmacovigilance System
- Act as PSMF Manager, managing the process and documentation relating to company's PV System Master File, ensuring its maintenance; act as primary liaison with other functional groups to coordinate maintenance of the appendices from various contributors
QPPV Office Management:
- Ensure appropriate processes, resources, communication mechanism and access to all sources of relevant information required for QPPV oversight and manage information received as hardcopy at the EU QPPV Office and electronically through the QPPV Office mailbox
- Maintain knowledge of EU PV legislation and, as appropriate, review and carry out impact analysis on Health Authority proposals for changes in pharmacovigilance regulations and guidelines
- Author PV Controlled Documents as necessary and act as owner for Controlled Documents relating to QPPV Office function
- Provide organizational training on QPPV requirements and general induction training to newcomers on PV system
- Collaborate with other functions in PV, including Alliance Management, Compliance, Regional Safety Office and Safety Evaluation team bringing QPPV Office perspective to initiatives and projects
Education, Skills and Experience:
- Experience in pharmacovigilance preferably gained in a European environment (min 3 years)
- Good knowledge of EU PV legislation and guidance
- Graduate level education or equivalent (life science, pharmacy or nursing degree would be an advantage)
- Excellent written and oral communication skills
- Strong team player with good organisation skills and ability to deal with multiple tasks
- Proven experience of proactively driving a variety of tasks and cross-functional projects
- Good attention to detail
- Ability to work independently when required
- Flexibility and adaptability.
- Willingness to travel if required.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Jon Stewart on +44 203 7520 318 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.