PV Process Lead

Key People

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Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :


Address 1 :

Western Europe,--Basel,Basel,

Key Skills :

drug safety, pv, pharmacovigilance, PV lead, leadership, DS

Salary :

€80 - €100 per annum

Date Posted :

29 Apr, 2019

Company Name :

Key People

Location1 :


Job Category :

Drug Safety Jobs

Experience :


Job Type:


Travel Amount:



Within this role you will provide principal subject matter expertise for the design, development, maintenance & support of core PDS processes. This is a key enabling and strategic role, ensuring that the client can continue to deliver effective scientific safety activities and/or PV system activities, in line with regulatory authority and internal stakeholder requirements.

The ideal candidate 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. This is an influential role in continuous improvement and ongoing process innovation in the safety arena.

*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) and with company 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. PDS Job Description 2
*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).

*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).
Desirable Experience:
*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.

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

Company Name:

Key People


Catherine House,Adelaide Street


Staffing Firms


United Kingdom






less than 100




St Albans

Phone No. :

01727 817 626

Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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