CK Group are recruiting for a PV Process Director to join a leading pharmaceutical company based in Welwyn Garden City on a 6-month contract basis. As a remote based contractor, you will need to attend the offices on occasion for meetings. The role has been deemed as Outside IR35.
PV Process Director Role:
The main purpose of the role will be to:
- Design, develop, maintenance & support of one or more core PDS processes, that are required to deliver effective scientific safety activities and/or PV system activities (ICSR management, signal management, and risk management).
- Serve as the principal subject matter expert for the assigned area(s) of process, working either in close partnership with accountable Global Process Owners.
- Potentially serve as a Global Process Owner and/or Business Process Owner for one or more assigned processes.
Further responsibilities will include:
- Maintaining expert knowledge of key regulatory and legislative changes and scientific best practices.
- Ensuring critical process requirements are defined as an input to the development of associated tools and technologies.
- Networking with internal & external groups understanding their needs and ideas; identifying and anticipating solutions and working collaboratively to find solutions.
To succeed in this role, you will have:
- A Life Science background or healthcare-related discipline.
- Relevant experience in pharmacovigilance and/or a clinical safety-related role.
- Practical experience of applying business process improvement methodologies.
- Good knowledge of regulatory pharmacovigilance requirements and guidelines published by the major global Health Authorities (FDA, EMA, MHRA).
- Prior experience in project management and/or business improvement is desirable.
- Awareness of ?benefits realization? approaches and change management activities that can ensure process improvements are sustained & measured.
Job ref 51256.
It is essential that applicants hold entitlement to work in the UK.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Hendre Moolman
- Phone: 01438 743 047
- Reference: 51256
Website: CK Group
- Posted: 2nd September 2021
- Expires: 30th September 2021