Pharmacovigilance & Regulatory Scientist (FT/PT)
PsiOxus are an exciting UK-based biotechnology company, specialising in the development of novel gene therapies for the treatment of cancer.
This is a new and unique opening that would particularly suit an enthusiastic scientist starting out in their career, or someone who has up to 1 years' experience in either pharmacovigilance or regulatory. This is a fantastic opportunity to develop experience and skills to manage regulatory submissions and oversee pharmacovigilance activities to support clinical studies in the US and Europe.
This is an office-based position located at our facility in Abingdon, Oxfordshire. We would be pleased to accept applications for both full time (37.5 hrs/wk), and part time/flexible working arrangements. Please state in your covering letter.
The PV & Regs Scientist will report directly to the VP of Regulatory Affairs and will manage Pharmacovigilance operations at PsiOxus, including overseeing vendor performance; and manage regulatory submissions to support on-going clinical trials, including overseeing CRO performance.
Key activities will include but are not limited to:
- Collaboration with project team colleagues to define the regulatory strategy and ensure optimal execution to support the conduct of clinical studies.
- Preparation of regulatory submission packages to support clinical trial applications.
- Management of CROs and vendors involved in regulatory submissions.
- Represent regulatory function at project team meetings.
- Maintenance of regulatory documentation related to the conduct of clinical trials in all regions.
- Oversee safety case processing and preparation of aggregate reports by external vendor.
- Support the preparation for and conduct of quarterly internal Safety Review Committee meetings.
- Support the identification of potential clinical safety signals and the development of risk prevention and/or mitigation measures to be implemented in clinical study protocols and/or investigator brochures.
- Review of clinical trial related documents such as protocols, investigator brochures, informed consent forms, study reports and development safety update reports.
- Contribute to the maintenance of the PsiOxus Pharmacovigilance system eg. SOPs, work instructions, pharmacovigilance agreements, document templates and vendor oversight.
We are looking for candidates with a life sciences degree and ideally (but not necessarily) 1 years’ experience in regulatory, pharmacovigilance or clinical operations functions.
If you are used to working in a fast-paced environment whilst retaining a high attention to detail, are highly organised and have excellent project management skills, bringing enthusiasm, strong interpersonal, collaborative and problem-solving abilities we would like to hear from you.
Strong oral and written communication is required together with the ability to work well with others in demanding situations with a positive attitude, demonstrating tact, diplomacy and respect.
In return we offer an attractive remuneration package including salary, pension, private healthcare and other benefits. To apply please click here and on the "Apply" button to upload your CV and covering letter.
The closing date for applications is Friday 19 July 2019, however applications will be evaluated in the order that they are received. You are therefore encouraged to apply as soon as possible.