The Scientific Enablement & Processes (SEP) organization is responsible for subject matter leadership and ownership of the critical PV processes owned by PDS and the development/acquisition of new methodologies, tools, and approaches for scientific enablement.
Reports to: Global Head, Scientific Enablement & Processes
Primary Responsibilities & Accountabilities include but are not limited to:
Responsible for effective line and performance management of global SEP team members in their reporting line and are coached, trained and developed in order to maximise their personal potential, wellbeing, and contributions to the business Anticipating resource needs and recruiting/developing talent, as required and in conjunction with the Global Head of SEP Accountable for the quality of their team's activities relating to the review, revision and development of PV processes Serving as 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 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 Roche 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
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 MD 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 10+ years of experience).
You will bring:
Demonstrable 'hands on' experience of delivering or managing safety and pharmacovigilance activities described by the assigned safety processes is desirable. 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. Excellent line-leadership skills, with proven ability to lead and manage multi-disciplinary teams, comprising diverse skillsets, in a global organization.
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.