Portfolio Safety Scientists (PCS-Sci) provide safety science and pharmacovigilance support to molecules across the Roche portfolio. As a group, they are responsible for all aspects of safety science/pharmacovigilance, with accountability being held by PCS leadership and experts or SSLs (Safety Strategy Program Leaders) depending on the deliverable/activity.
The Portfolio Safety Scientists (PCS-Sci) supports early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management across the entire development and marketed portfolio. In the post-market setting this may include and may include signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management. The Associate Director will be expected to work with minimal supervision and apply strong self-leadership. The job holder will be expected to identify areas of development and complete the required training.
Under the matrix leadership of the SSL and in collaboration with PCS colleagues
● Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas. Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action)
- ● Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER)
- ● Responsible for signal detection and management activities including, but not limited to STAR maintenance, ISMP maintenance. Contribute to the strategy and review of safety assessments and drug safety reports for signals or issues (inc, product quality) or in response to Regulatory Authority requests
- ● Contribute to the development of the product safety strategy and provide drug safety input into the Clinical Development strategy
- ● Contributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance (including the IB), risk communications, RMP, REMS
- ● Contributing to study management from a safety perspective through SMT/PET activities and document review and maintenance across the development continuum (early phase to post marketing studies), including PASS
- ● Contribute to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with SPL
- ● Responsible for the preparation and maintenance of safety sections of the Company Core Data Sheet and/or Reference Safety Information in the IB
- ● Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable
- ● In partnership with the SSL, support presentation of important safety issues to the Drug Safety Committee (DSC), Development Review Committee (DRC) and other internal and external review and governance committees as needed.
- ● Author or contribute to scientific publications (abstracts, posters, papers) for scientific meetings/journals
- ● Acts independently to manage safety responsibilities on study teams and in activities supporting safety science
- ● Take on the responsibility for specialised roles with PCS. These may include, but are not limited to; functional business process owner, subject matter expert.
Behaviours and Responsibilities
- ● Demonstrates independence and high competence in the conduct of all safety science responsibilities
- ● Actively emulate and role model the Roche values, culture (mindset and behavior), Roche core competencies and PD/PDS strategy and drive for similar performance across relevant team
- ● Demonstrates behaviors consistent with Roche values and engenders confidence from senior management
- ● Develop and maintain knowledge of the pharmaceutical industry and drug development, including a comprehensive knowledge of pharmacovigilance activities and requirements
- ● Ensure all actions are conducted in alignment with Roche quality management systems
- ● Understands how safety activities contribute to company development and commercialisation goals and takes measures to maximize safety value to the organization
- ● Establish and maintain collaborative working relationships with all key stakeholders, and internal and external customers and ensure the same across relevant teams
- ● Consistently comply with all governing laws, regulations, Roche standard operating procedures (SOPs) and other guidelines
- ● Responsible for coordination and collaboration with vendors servicing Safety Science
- ● Acts independently and with minimal supervision to manage safety responsibilities on study teams and in activities supporting safety science
- ● Trains and mentors more junior PSS scientists
- ● Proactively takes on responsibility for more complex deliverables
- ● Takes on team leadership responsibility in order to manage and complete medium and high priority projects
- ● Seen by peers and cross-functional colleagues as expert in some safety science activities
- ● Under certain conditions, may take on the role of “Safety Strategy Lead (SSL)” for one or more assigned molecules. The SSL is the lead safety accountable for the molecule safety strategy.
- ● Willing to challenge embedded behaviors/mindsets, in order to bring new and agile approaches to ways of working, and/or to improve quality and efficiency.
- ● Holds themselves and peers accountable for their behaviours and actions.
Education, Skills and Experience:
Minimum Qualifications: Qualified healthcare professional or Life Sciences graduate.
A relevant postgraduate qualification (e.g. PHD/MSc in a Life sciences discipline; PharmD or other post-graduate health professional qualifications) would be advantageous.
Principal Scientist (lvl 3): 4 or more years of drug development experience in the pharmaceutical or related industry including at least 2 years in drug safety or a closely related field.
- ● Understanding of GxP and regulated processes and end to end clinical trial lifecycle
- ● Strong orientation towards process improvement and cross-functional teamwork
- ● Effectively work with remote partners on a global team
- ● Excellent communication skills, both written and verbal
- ● Apply complex data analysis / statistical methods to evaluate, interpret and present scientific data with clarity
- ● Strong presentation skills, effective at summarizing and presenting the key considerations and decision points
- ● Ability to effectively train others on departmental practices and processes
- ● Application of project management methodology
- ● (For roles in China) Fluent in Mandarin and English