This position within the Product Development organization, in Safety Risk Management will report to Group Head of PV Processes. Provides tactical support for the Global Head (GH) of Scientific Enablement and Processes (SEP), PV Process Leaders, and Scientific Enablement Leaders in the PDS - Scientific Enablement and Processes team. Contributing to the execution of new strategic objectives, activities to maintain and develop the core PDS processes (e.g. Individual Case Safety Report management, Signal Management, Risk Management, etc), and support of projects and tasks for scientific enablement. Primary responsibilities include involvement in the design and development of processes, aligned with the goals of the PV Process Leaders and other senior PDS stakeholders involved in the assigned areas and tactical support of the Scientific Enablement Leaders in embedding new methodologies, practices, etc. to accelerate the progression of drugs through the discovery pipeline and ensure PDS delivers value to the drug portfolio. Also project management support of training and implementation of new and existing core PDS processes and their documentation. In addition the role supports safety teams in the execution of the core PDS processes, along with metrics surveillance and quality control. The Sr. Process Scientist has an important role in supporting the SEP group to perform continuous process improvement and ongoing process and scientific innovation in the safety arena at Roche.
Primary Responsibilities and Accountabilities:
Support the GH and the Leaders of SEP in completing identified tasks and deliverables in connection with routine support provided to various teams in respect to the core PDS processes and scientific enablement Assist in the completion of projects and new strategic initiatives by managing logistics, integrating with teams, attending meetings, and following through on assigned tasks Triage, and organize requests for SEP support from the wider organization (PDS and other functions) Expand the reach of the GH and the Leaders of SEP and the group's overall effectiveness by maintaining contact/dialogue with key stakeholders (e.g. within PDS, with cross-functional teams (e.g. GDTs, LCTs) and/or working groups) already established by the SEP group and to triage and disseminate new requests to maximize SEP involvement Contribute in the development of new tools under the leadership of the GH and the Leaders of SEP Support the quality management of the core PDS processes under the supervision of the PV Process Leader and in collaboration with other stakeholders Keep abreast of new developments in the core PDS processes to have proper context in support of the PV Process Leader and successful completion of assigned tasks
Who you are
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.We are looking for a professional with MSc or a degree in a life science or healthcare-related discipline (e.g. PharmD, nursing, dentistry, etc.) and relevant experience in pharmacovigilance and/or a clinical safety-related role (typically 3+ years of experience). Desired a higher qualification in a relevant discipline (e.g. pharmacovigilance, epidemiology, operations management, lean sigma, etc), depending upon the required areas of process development expertise.
You will bring:
Familiarity with one or more core PDS processes (e.g. ICSR management, signal management, risk management) and/or other critical supportive processes (e.g. benefit-risk assessment, aggregate reporting, etc). Familiarity with regulatory pharmacovigilance requirements and guidelines published by the major global Health Authorities (e.g. FDA, EMA, MHRA, etc). Experience in project management desirable and ability to operate effectively in a multifunctional, matrix team Excellent written and verbal communication skills. Fluent in English (verbal and written) Attention to detail -good prioritization and organization skills Good computing/IT skills Additional Information:
Occasional international business travel will be required
Who we are
Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites.Read more. Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.