Overview
The CTC designs and conducts high quality clinical trials, from phase I to phase III trials, with a range of treatments including chemotherapies, radiotherapy, surgery and targeted therapies including advanced cell and gene therapies.
Role
This post will sit within the CTC Regulatory team, and with the support of the Pharmacovigilance (PV) Manager, will maintain oversight of safety reporting activities within the CTC, ensuring patient safety and regulatory compliance at all times. The postholder will review SUSAR reports, raise queries with trial teams and make timely submissions into ICSR Submissions and EudraVigilance portals. They will maintain oversight over SUSAR submissions and review and submit DSURs to the REC and MHRA.
Responsibilities
- Review SUSAR reports and raise queries with trial teams.
- Submit timely ICSR submissions and report into EudraVigilance portals; maintain oversight of SUSAR submissions.
- Review and submit DSURs to the REC and MHRA.
- Adhere to regulatory requirements and ensure patient safety responsibilities are maintained across the CTC.
Requirements / Qualifications
- Significant knowledge of biomedical or life sciences, and substantial experience of pharmacovigilance in an academic sponsor setting.
- Experience in safety reporting to competent authorities and REC, using ICSR submissions and EudraVigilance; ability to prepare DSURs is essential. Knowledge of cancer biology and treatments would be advantageous.
What we offer
- This is a full-time, open-ended post funded for 1 year in the first instance. Appointments usually made at the bottom of the scale.
- Hybrid working with a minimum of 60% office attendance.
- 41 days holiday (27 days annual leave, 8 bank holidays, 6 closure days).
- Additional 5 days’ annual leave purchase scheme.
- Defined benefit CARE pension scheme.
- Cycle to work scheme and season ticket loan.
- Immigration loan and relocation scheme for certain posts.
- On-site nursery and on-site gym.
- Enhanced maternity, paternity and adoption pay; Employee assistance programme.
- Discounted medical insurance.
Equality, Diversity and Inclusion
As London’s Global University, we are committed to equality of opportunity, fairness and inclusion. We particularly encourage applications from candidates who are underrepresented in UCL’s workforce, including Black, Asian and ethnic minority backgrounds; disabled people; LGBTQI+ people; and, for our Grade 9 and 10 roles, women. Our department holds an Athena SWAN Gold award for advancing gender equality.
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