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
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.
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