A brand new role has been created in Welwyn to support the EU QPPV/QPPV office to ensure full oversight and quality of Pharmacovigilance (PV) processes and of the quality system for PV.
Working within the PDS (Product Development Safety) QPPV Office in Welwyn, you will report to the QPPV Office manager and will have the opportunity to lead and oversee safety positions. Your excellent knowledge and experience within EU PV regulations and policies will be absolutely key to the success of this role.
Within this role you shall have full responsibility for ensuring the maintenance of the PSMF which will include creating updated schedules, managing updates, ensuring review and content accuracy while driving process improvement, working with content owners, stakeholders and IT.
You will also ensure documents that fall under the responsibility of the QPPV Office are maintained and continuous evaluation and refinement of existing PV processes to ensure compliance with regulations and guidelines.
Within this role you will also be expected to collect/create/review PV relevant metrics and other relevant data (e.g., updates, presentations) to support oversight of:
- ICSR, PSUR, RMP, signal detection, safety communication including safety labeling changes, PV commitments.
You will lead and/or project manage PV improvement efforts/QPPV Office led initiatives/projects:
- Plan and execute PV improvement/implementation projects
- Identify and assess impact on all stakeholders, processes and tools and manage the communication accordingly
- Effectively facilitate project team meetings and lead them (when acting as project leader)
- Organize meetings and workshops
- Keep the QPPV Office Management regularly informed about all project aspects
- In the absence of a change manager acts as the change manager
As an expert within the department, you shall provide training on the roles and responsibilities of the EU QPPV in relation to the existing EU regulations as required, and give EU PV Regulations Awareness sections and training on selected PV topics.
Due to the nature of this position, it is important to keep permanently up to date on EU PV regulations and policies, and assess the likely impact of new EU regulations and guidelines on Roche.
Who are you
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies.
Where a job title is not considered the final definition of who you are, but the starting point.
To be successful within this role you will be educated to a minimum of bachelor’s degree level in health care profession or relevant life science or natural science discipline. A further qualification/certification in project management methodologies is desired.
It is essential that you understand and maintain knowledge of PV regulations and guidelines and have solid experience in different PV processes (e.g., ICSR and safety science processes).
Proven experience of proactively driving a variety of tasks and cross-functional projects and delegating to team members is crucial and with that should come excellent organizational and communication skills.
You will also be able to demonstrate persuasion and influencing skills, be able to deal with diversity, ambiguity and multi-tasking. Excellent Word, Excel and Powerpoint skills are required.
August, 5th 2012
The next step is yours. To apply today, click on the "Apply online" button below.
Roche is an Equal Opportunity Employer
- 10 months ago