Pv Business Process Leader

2 weeks ago


Welwyn, United Kingdom Clearline Recruitmentment Ltd Full time

Our client, a global name in Pharmaceuticals, is one of the top 100 companies to work for in the UK, and they are looking to hire an PV Business Process Leader to join their team on a 12-month contract.

**Responsibilities**
- Drive the continuous evaluation and refinement of global Affiliate PV processes and corresponding systems/tools to ensure quality and compliance with regulations and guidelines
- Collaborate with global process owners to influence global PV processes impacting Affiliate
- Design, influence and review PV relevant metrics and other relevant data to support global and regional oversight, supporting the data capture in the adequate platforms for local and regional reports
- Ensure adequate input from an appropriate set of Affiliate staff during the design phase of global processes and ensure the process communication and training meets the Affiliate needs
- Detects and escalates issues impacting global PV processes or potentially impacting multiple Affiliates as appropriate
- Lead and/or contribute to PV improvement efforts, PV initiatives and projects in close collaboration with IPV Community Heads, CCLs and global process owners
- Identify and assess impact on all stakeholders, processes and tools and manage associated communications accordingly
- Plan and execute Affiliate PV improvement/implementation projects (e.g. Affiliate PV Manual)
- Effectively lead and facilitate project team meetings (when acting as project leader)
- Support affiliate implementation and change management
- Establishes best practices across Affiliates compliance
- Escalate issues impacting global PV processes
- Serve as a point of contact for between Affiliate and Headquarter for PV relevant communications
- Collaborate in the continuous improvement activities for the IPV Business Process Management team

**Requirements**:

- Scientific qualification (PhD or MSc) in healthcare profession or relevant life science or nature science discipline, or equivalent professional experience
- Further qualification/certification in project management methodologies and/or change management strongly desirable
- 10 or more years PV, clinical research, development, drug safety science or related experience
- 3 years minimum in Affiliate PV roles or a global role focusing on Affiliate support
- Broad understanding of global and Affiliate PV processes, including safety Affiliate roles
- Additional experience in regional and/or headquarter roles is desirable - specifically PV operational knowledge and knowledge of risk management
- Past experience working with health authorities
- Experience in process design and process-level oversight (in particular for the processes mentioned as primary focus)
- Demonstrated experience of proactively driving a team in a variety tasks, projects and team management
- In-depth knowledge of PV, GVP, ICH-GCP and other relevant standards and guidelines
- Well-versed in medical and safety aspects of FDA, EMEA, NICE and other relevant regulations
- Good project and process management skills: can prioritize multiple tasks and goals to ensure timely, on-target and within-budget accomplishment of such
- Past experience as Business Process Owner is of advantage
- Strong interpersonal skills: proven abilities to work effectively and efficiently in cross-functional, often virtual and matrix teams
- Good influencing and negotiation skills: proven abilities to influence others without authority
- Good communication (including social media publishing) and presentation skills; exhibits professional maturity, confidence, and competence. Knows how to summarize and communicate the key points and business case for others to effectively and expeditiouslymake important decisions
- Willingness and ability to travel internationally, as required

**Job Title**:International PV Business Process Leader

**Location**:Welwyn - Hybrid 2/3 days a week in office

**Salary**:£500 - £650 LTD/UMB

**Full Time**

**12-month contract, Outside IR35**

**For more information, and a full job description, please contact Chloe Mccausland at Clearline Recruitment.


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