For our Swiss customer located in Basel we are currently looking for (m/f) a Principal PV Process Leader - PHARMA
- Type of placement: 1 year, external contract with possible long term extension
- Company: major Pharma company in Basel area
- Salary: level 3, please ask us for the exact rate range
(monthly gross salary levels in CHF, level1= 5-10k , level2=10-15k, level3= >15k)
Function: Safety Risk Management (PDS)
Department: PV & Scientific Development – Scientific Enablement and Processes (SEP)
Location: SSF, Basel, or Welwyn
Reports to (Position Title): Global Head of Scientific Enablement and Processes (SEP)
Serve as a senior member of the SEP 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 PDS processes. This is a key enabling and strategic role, ensuring that our customer 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 an extensive understanding of all aspects of the internal and external environment, in the areas relating to their assigned core PDS processes, typically being recognised externally as an industry expert in their field. They will collaborate closely with senior stakeholders across the business including but not limited to; 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
- Serving as a Global Process Owner and/or Business Process Owner for one or more assigned process(es).
- Responsible lead role in the design, development, maintenance & support of one or more core PDS processes of the highest business complexity, that are required to deliver effective scientific safety activities and/or PV system activities (e.g. global ICSR management, signal management, risk management, etc).
- Serving as the lead principal subject matter expert (SME) for the assigned area(s) 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 PV and Scientific Development & PDS. PDS Job Description Principle PV Process Leader, V1.0, Approved Date 1 Jul 2015
- 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.
- Collaborating closely with the Scientific Enablement Leaders and guiding other SEP staff via the Center(s) of Excellence or other available mediums to achieve scientific innovation and enablement in their assigned process(es).
- Building and strengthening relationships within our customer (e.g. within PDS, with cross-functional teams (e.g. GDTs, LCTs) and/or working groups) and with our customer 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 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 and leadership to the communication, training, implementation, follow-up and feedback, relating to assigned processes.
- Serving as a role model across PDS and 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.
- Providing effective leadership in resolving conflict and negotiating with affected stakeholders in respect to complex change& implementation issues.
- 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 7+ 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
- International business travel up to 15% of the time may be required, depending upon the business location of the jobholder.