Senior Pharmacovigilance Scientist

Location
Welwyn Garden City
Salary
Circa £45 phr
Posted
16 Apr 2021
Closes
16 May 2021
Ref
50387
Contact
Hendre Moolman
Hours
Full Time
Contract Type
Contract
Experience Level
Senior Management
CK Group are recruiting for a Senior PV Quality Specialist to join a pharmaceutical company at their site based in Welwyn, working remotely on a contract basis for 12 months. Role outside IR35.

The Company:
Our client is a world leading innovative pharmaceutical company that is committed to improving the lives of patients.

The Role:
The main purpose of the role will be to:
- Collect, analyse and report quality and compliance data to ensure adherence to internal/external standards
- Support PV/GCP Safety Inspections & Audits, providing support for Deviations and Corrective Actions/ Preventive, and support or lead aspects of procedural document management and other PV QMS activities.
- Lead the development of process documentation or groups of documentation, including process mapping and providing expertise to ensure processes are designed to meet quality objectives

Further responsibilities will include:
- Identifying data trends or process deficiencies, ensuring that deviations are appropriately reported and ensuring PV process improvements
- Production of the Pharmacovigilance System Master File PSMF for PV system compliance
- Supporting or leading preparation and conducting of internal process audits for PDS owned processes, specifically in the area of document request management

Your Background:
To succeed in this role, you will come from a Life Science background, with experience of data collection, management, reporting, or auditing
- Knowledge of CAPA processes required and experience of managing CAPA related activities desired.
- Good knowledge of key GVP regulatory requirements, in particular those relating to quality and quality management systems.
- Good understanding/experience in one or more specific area of GVP or Clinical Trial safety

Entitlement to work in the UK is essential. Please quote reference 50387.

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