PV Process Director (remote-based)

Hobson Prior are seeking a PV Process Director to join the UK team at a world-wide pharmaceutical organisation focused on the research and development of novel medicines and marketing them once they have been developed. In this role you may be remote based.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Collaborating closely with the Scientific Enablement Leaders to achieve scientific innovation and enablement in their assigned processes.
• 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 the company's partners.
• Influencing externally in the assigned areas of expertise (e.g. involvement in expert working groups or industry associations, external policy influence) and promoting the company's activities externally (e.g. via publications or scientific conferences).
• 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 risk management).
• Serving as the principal subject matter expert for the assigned areas of process, working either in close partnership with accountable Global Process Owners or Business Process Owners.
• Maintaining awareness of external trends & anticipating future requirements or opportunities in assigned areas of process expertise.
• Identifying, sharing & promoting good practice and innovation, both regarding the assigned processes 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 processes.
• Maintaining expert knowledge of key regulatory and legislative changes and scientific best practices in the assigned SME areas 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 areas 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.
• Demonstrating the ability to influence broad groups of stakeholders, adopting a range of influencing styles and/or communication techniques.

Key Skills:

• The ideal candidate will be organized, self-motivated and flexible.
• Good attention to detail but also able to prioritize and plan activities in line with both personal and wider business priorities.
• Ability to operate effectively in, and lead as needed, multi-functional matrix teams.
• Proficient IT skills with the ability to use relevant software/systems applicable to the role (e.g. MS Office applications, Google applications, dedicated safety or clinical IT systems, etc).

Requirements:

• The ideal candidate will have prior experience in project management and/or business improvement is desirable.
• Demonstrable 'hands on' experience of delivering or managing safety and pharmacovigilance activities described by the assigned safety processes is desirable.
• Good knowledge of regulatory pharmacovigilance requirements and guidelines published by the major global Health Authorities (e.g. FDA, EMA, MHRA, etc).
• A broad understanding of pharmaceutical drug development is advantageous.
• A general understanding of pharmacoepidemiology and its potential application to safety related activities would be an advantage.
• Awareness of 'benefits realization' approaches and change management activities that can ensure process improvements are sustained & measured.
• Able to manage budgets and ability to manage external vendors is greatly desired.
• Excellent written and verbal communication skills (must be fluent in English) and the ability to present and critically discuss clinical data in relation to its significance and impact on the core safety processes in both internal and external discussions.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.