Cancer Trials PV Officer (Fixed-Term)

The Royal Marsden NHS Foundation Trust; Sutton No. 103; On-site; CAD 84,000 - 112,000; Full time

Job summary

The Royal Marsden NHS Foundation Trust is seeking a Pharmacovigilance Officer (maternity cover) to support sponsor oversight of safety aspects in clinical trials and other studies. You will work within the GCP & Regulatory Compliance Team to ensure compliance with UK legislation and overseas requirements where applicable.

Candidates should have experience working to GCP standards and in pharmacovigilance. The role may be offered as a secondment for internal applicants with line manager approval;

Qualifications

• Experience working to GCP standards.
• Experience in pharmacovigilance.
• Able to provide expert pharmacovigilance support to clinical research teams.

Responsibilities

• To provide support and expert advice to clinical research teams in developing pharmacovigilance sections of new clinical trials protocols.
• To assist in the reporting of SUSARs and Serious Breaches to the MHRA and REC.
• To monitor pharmacovigilance processes and their reporting, escalating issues when required.
• Co-ordinate and perform pharmacovigilance audits in preparation for Developmental Safety Update Reports (DSURS) production and submission.
• To co-ordinate and assist in the production and submission of Developmental Safety Update Reports (DSURS) to the MHRA.

Skills

GCP standards

Pharmacovigilance

Clinical research teams collaboration

Job description

The Royal Marsden NHS Foundation Trust is seeking a Pharmacovigilance Officer (maternity cover) to support sponsor oversight of safety aspects in clinical trials and other studies. You will work within the GCP & Regulatory Compliance Team to ensure compliance with UK legislation and overseas requirements where applicable.

Candidates should have experience working to GCP standards and in pharmacovigilance. The role may be offered as a secondment for internal applicants with line manager approval;