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PV Process Director - 12 month contract

Hertfordshire   •  £55 - £70 per hour  •  Contract/Temporary, Full time


Job Purpose:
Provides principal subject matter expertise for the design, development, maintenance &
support of core PDS processes. This is a key enabling and strategic role, ensuring that
can continue to deliver effective scientific safety activities and/or PV system activities,
in line with regulatory authority and internal stakeholder requirements. The jobholder will
have a sound understanding of the key aspects of the internal and external environment that
relate to their assigned core PDS processes and they will collaborate closely with senior
stakeholders across the business, including Global Process Owners and Business Process
Owners, The QPPV and members of product- and process-related working groups and
governance bodies. This is an influential role in continuous improvement and ongoing
process innovation in the safety arena.

Primary Responsibilities and Accountabilities:
? 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 (SME) for the assigned area(s) of
process, working either in close partnership with accountable Global Process Owners
and 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 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 (e.g. within PDS, with
cross-functional teams (e.g. GDTs, LCTs) and/or working groups).
? Influencing externally in the assigned areas of expertise (e.g. involvement in expert
working groups or industry associations, external policy influence) and promoting 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.
? Demonstrating the ability to influence broad groups of stakeholders, adopting a range
of influencing styles and/or communication techniques.

Education/Qualifications/Experience:
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.
? Practical experience of applying business process improvement methodologies.
? 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 ?hands on? 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 (e.g. FDA, EMA, MHRA, etc).
? A general understanding of pharmacoepidemiology and its potential application to
safety related activities would be an advantage
? 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
? 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.
? Organized, self?motivated and flexible.
? Attention to detail but also able to prioritize and plan activities in line with both
personal and wider business priorities.
? 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)
? Able to manage budgets and ability to manage external vendors is greatly desired

Additional Information:
? Occasional international business travel will be required

For further details, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@achieva.co.uk

  • Agency: Achieva Group Limited
  • Reference: BH-33286
  • Posted: 13th May 2022
  • Expires: 10th June 2022

Achieva Group Limited

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