Principal PV Process Leader


Reference Number: 895636-W
Type of placement: Contract, Contract, 12 Months
Location: Switzerland, North West


The Principal PV Process Leader role serves as a senior member of the Scientific Enablement and Processes organization by operating as Global Process or Business Process Owner and providing lead Principal Subject Matter expertise for the design, development, maintenance & support of core Product Development Safety processes. The jobholder will have an extensive understanding of all aspects of the internal and external environment, in the areas relating to their assigned core product development safety processes, typically being recognised externally as an industry expert in their field. The Principal PV Process Leader will collaborate closely with senior stakeholders across the business.

Main Responsibilities:

  • Serving as a Global Process Owner and/or Business Process Owner for one or more assigned processes
  • Responsible lead role in the design, development, maintenance & support of one or more core Product Development System processes of the highest business complexity; those are required to deliver effective scientific safety activities and/or Pharmacovigilance system activities (e.g. global ICSR management, signal management, risk management, etc)
  • Serving as the Lead Principal Subject Matter Expert for the assigned areas of process, working in close partnership with other cross-functional Global Process Owners and Business Process Owners and anticipating strategic requirements in respect to the assigned process
  • Maintaining awareness of external trends & anticipating future requirements or opportunities in assigned areas of process expertise
  • Influences and implements the strategic vision of Pharmacovigilance and Scientific Development & Product Development Safety
  • Identifying, sharing & promoting good practice and innovation, both with regard to the assigned processes and the utilisation of process improvement methodologies:  Providing guidance to ensure process continuity, consistency & alignment
  • Collaborating closely with the Scientific Enablement Leaders and guiding other Scientific Enablement and Processes team members via the Centers of Excellence or other available mediums to achieve scientific innovation and enablement in their assigned processes
  • Building and strengthening relationships within Product Development System team and with partners
  • Serving as a team leader/chairperson of expert working groups or committees, required to support assigned processes or lead improvement programs
  • 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 subject matter expert 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
  • Providing subject matter expert 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 Subject Matter Expert 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 Subject Matter Expert input and leadership to the communication, training, implementation, follow-up and feedback, relating to assigned processes
  • Serving as a role model across Product Development Systems and promoting a culture of continuous process improvement, innovation and a solution-orientated mind-set
  • 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
  • Providing effective leadership in resolving conflict and negotiating with affected stakeholders in respect to complex change& implementation issues

Qualifications and Experience:

  • MD or a degree in a life science or healthcare-related discipline (e.g. PharmD, nursing, dentistry, etc)
  • A higher qualification in a relevant discipline (e.g. pharmacovigilance, epidemiology, MBA, pharmaceutical medicine, etc) would be an advantage
  • 7+ years experience in pharmacovigilance and/or a clinical safety-related role
  • 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
  • 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 pharma epidemiology 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 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
  • Fluent in both written and spoken English
  • 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
  • International business travel up to 15% of the time may be required
  • Relevant working/residency permit or Swiss/EU-Citizenship required