Hendre Moolman is recruiting for a Global Compliance Analyst to join a company in the pharmaceutical industry on a 12 months fixed term contract role in Hertfordshire.
As Global Compliance Analyst you will be responsible for PV project management and process improvements to ensure successful project implementation, open communication, and expertise on initiatives to key stakeholders.
Further responsibilities of Global Compliance Analyst position will include:
- Quality and metrics, for adherence to PDS standards and processes through partnerships with safety operations, safety sciences, safety affiliates and other compliance departments.
- Global PV inspections management and support, both face-to-face and virtually, including ad-hoc travel for on-site support.
- PDS deviations and CAPA management to support PDS and affiliates in creating quality deviation reports and CAPA responses.
As Global Compliance Analyst you will have the following qualifications, skills and experience:
- A bachelor's degree, preferably in nursing or pharmacy, with significant experience in clinical and safety combined.
- Experience in assessing adverse events and clinical information, and have a good level of proficiency in adverse event databases, including ICSR experience
- Experience in the currently used database, ARISg. Argus experiece is acceptable too.
- Data auditing and inspections experience is desirable (root cause analysis)
- Product safety experience with sound knowledge and understanding of FDA, GvP and ICH regulations and guidelines would be beneficial
- Excellent knowledge and understanding of FDA, GvP, and related regulatory documents, ICH guidelines and national/international GCP requirements
How to apply:
For more information or to apply for this Global Compliance Analyst position please contact Hendre Moolman on +44 (0)1438 842 970 or email firstname.lastname@example.org quoting the job reference 27257.