A global pharmaceutical client is looking to expand their Pharmacovigilance team based in Hertfordshire due to continued growth and expansion. This organisation is at the forefront of drug development and research within the global pharmaceutical industry, providing exceptional opportunities for career growth and development.

The Research and Development arm of the organisation requires an individual to oversee, coordinate and streamline the use of their products in clinical trials, in line with key regulations.

In this role you will be:

• Working closely with numerous internal and external stakeholders, managing inspections and audits
• Creating corrective/preventative actions (CAPAs)
• Inputting into root cause analysis (RCA) effectiveness checks
• Coordinating documentation, including archiving and retrieval of key documents
• Managing a team of 10 scientists
• Ensuring that case managements activities comply with internal and external standards
• Working closely with managers and directors within the business

The ideal candidate will:

• Have knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP)
• Have demonstrable experience working with clinical safety documentation and reporting of adverse events
• Demonstrate a strong understanding of national and global regulatory requirements
• Hold technical expertise and understanding of clinical trial safety processes
• Be confident in the oversight of case management activities

If you would like to hear more about this role or would like to discuss next steps into a career in Pharmacovigilance, please contact Helen on [email protected]

Tagged as: CAPA, case management, GCP, global regulatory, gvp, Pharmaceutical, pharmacovigilance, rca, Root Cause Analysis