Pharmacovigilance Process Leader

Key People

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Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :

Bsc,Medical Doctor,phD

Address 1 :

Western Europe,--Basel,Basel,

Key Skills :

pv, pharmacovigilance, qppv, drug safety

Salary :


Date Posted :

26 Apr, 2019

Company Name :

Key People

Location1 :


Job Category :

Pharma Research & Development Jobs

Experience :


Job Type:


Travel Amount:



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 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 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.

 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).
 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

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.

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