Pv Process Director
4 weeks ago
**Job Title**: PV Process Director
**Location**:Welwyn
**Salary**:£70 per hour (LTD)
**Full Time**
**12-month contract (outside of IR35)**
**Responsibilities**
- Responsible lead role in the design, development, maintenance & support of one or more core PDS processes, that are required to deliver effective scientific safety activities and/or PV system activities (e.g. ICSR management, signal management, and riskmanagement)
- Maintaining awareness of external trends & anticipating future requirements or opportunities in assigned areas of process expertise
- Identifying, sharing & promoting good practice and innovation, both with regard to the assigned process(es) and the utilisation of process improvement methodologies: Providing guidance to ensure process continuity, consistency & alignment
- Potentially serving as a Global Process Owner and/or Business Process Owner for one or more assigned process(es)
- Collaborating closely with the Scientific Enablement Leaders to achieve scientific innovation and enablement in their assigned process(es)
- Building and strengthening relationships within the company (e.g. within PDS, with cross-functional teams (e.g. GDTs, LCTs) and/or working groups) and with partners
- Influencing externally in the assigned areas of expertise (e.g. involvement in expert working groups or industry associations, external policy influence) and promoting company activities externally (e.g. via publications or scientific conferences)
- Maintaining expert knowledge of key regulatory and legislative changes and scientific best practices in the assigned SME area(s) and ensuring future changes are anticipated and planned
- Collaboration and close interface with internal policy governance bodies/stakeholders (e.g. EU QPPV, Drug Safety Committee, GVP Council, etc.) in adapting core processes in line with business needs and external requirements
- Ensuring business case proposals for key improvement programs in the assigned process area(s) are created for relevant governance teams (e.g. NMPc)
- Providing SME input/leadership into activities designed to promote continuous improvement and gather broad organisational input to potential process improvements and ideas or opportunities for further innovation
- Providing SME input/leadership to project prioritisation and capacity management activities
- Ensuring critical process requirements are defined as an input to the development of associated tools and technologies, in partnership with internal and external informatics & IT system roles and providers, where relevant
- Responsible for providing relevant SME input to the communication, training, implementation, follow-up, and feedback, relating to assigned processes
- Promoting a culture of continuous process improvement, innovation, and a solution-orientated mindset
- Networking with internal & external groups to understanding their needs and ideas; identifying and anticipating solutions and working collaboratively to find solutions
**Requirements**:
Minimum:
- MD or a degree in a life science or healthcare-related discipline (e.g. PharmD, nursing, dentistry, etc.)
- Relevant experience in pharmacovigilance and/or a clinical safety-related role (typically 5+ years of experience)
Desired:
- A higher qualification in a relevant discipline (e.g. pharmacovigilance, epidemiology, MBA, pharmaceutical medicine, etc.), depending upon the required areas of process expertise
- Proven ability to influence external policy (e.g. involvement in external working groups) and/or senior stakeholder decisions within a relevant business setting
Experience, Skills, Knowledge:
- Demonstrable experience of delivering or managing safety and pharmacovigilance activities described by the assigned safety processes is desirable
- A broad understanding of pharmaceutical drug development is advantageous
- Good knowledge of regulatory pharmacovigilance requirements and guidelines published by the major global Health Authorities
- 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
- Ability to operate effectively in, and lead as needed, multi-functional matrix teams
For more information and a full job description, please contact Chloe McCausland at Clearline Recruitment.
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