My client, a Top 10 global pharmaceutical company, are searching for a PV Process Director to join their team based in Hertfordshire. This is a fully remote based role and sits within the Risk Management Function.
Within this role you will act as the 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.
Primary Responsibilities and Accountabilities:
- 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
- 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).
- 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.
- 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
For further details, please contact Tim Barratt on +44(0)1727 817 626 or email a copy of your CV to email@example.com
- Agency: Achieva Group Limited
- Contact: Tim Barratt
- Phone: 01727811634
- Reference: BH-32690
Website: Achieva Group Limited
- Posted: 14th January 2022
- Expires: 11th February 2022