This candidate actively participates in and assists the management and maintaining the quality and compliance of the output of the Global Pharmacovigilance Risk Management (PVRM) organization through development and execution of global and departmental processes, PV standards, Pharmacovigilance Risk Management training program, and compliance monitoring systems.
- Main focus of this role is to track CAPAs and assist in the development of other members of the team.
- Provide project management for special projects as directed by the Head of Pharmacovigilance (PV) Compliance and Training and/or PVRM management.
- Assist the root cause analysis and corrective/preventative actions (CAPAs).
- Develop process and conduct trend analysis and liaise internally and externally to identify root case and CAPA.
- Maintain all documentation inspection-ready.
- Assist with creating/revising assigned procedural documents including cross-functional documents.
- Liaise with PVRM and cross-functional subject matter experts (SME) as necessary.
- 2-5 years of PV experience; 1-2 years experience with CAPAs.
- Basic knowledge of Quality Management Systems as well as FDA/EU regulations and ICH guidelines for GXP or devices.
- Knowledge of GVP
Sthree US is acting as an Employment Business in relation to this vacancy.