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Under the matrix leadership of the Safety Strategy Leader (SSL) and in collaboration with Portfolio Clinical Safety (PCS) colleagues to:
● 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.
(Responsibilities due to medical qualifications)
They will provide clinical medical expertise and decision-making, in areas where this is specifically required to support colleagues in PCS. Situations where qualified clinical medical input may typically be sought could include, but are not limited to:
● Interpretation of emerging safety-relevant data, in the context of experience gained whilst practising in relevant areas of clinical medicine/healthcare.
● Defining types of safety question or safety issue, in the context of a molecule/program, that may require specific clinical medical safety assessments or decisions to be made.
● Performing medical practice impact assessments in the context of product quality safety issues (e.g. as part of defined activities outlined in PT-managed processes that require formal assessment by medically qualified individuals).
● Determining the potential clinical medical impact of non-clinical safety findings, and/or the interpretation of potential product risks associated with such findings, in the context of current external clinical practice.
● Providing advice and interpretation of whether/how risks may impact the overall clinical risk-benefit balance of an asset, in the context of typical clinical medical practice in the territories/countries where the product/asset will be used.
● Making formal company medical assessments that may be required from PDS, with regard to the suspected causal relationship between reported events and treatment. For example, where this is required in the context of the management of Individual Case Safety Reports (ICSRs) requiring assessment.
● Review of clinical study development plans and/or study protocols (and other relevant clinical trial documentation), to ensure their design is appropriate to current clinical medical practice. In addition, to ensure that the measures outlined in plans/protocols to manage defined patient risks, are appropriate/feasible to implement in the context of current clinical medical practice, and can reasonably be expected to achieve the clinical risk management aims that have been described in relevant risk management plans.
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 PCS 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:
- Formal medical qualifications (e.g. MD; MB BS; MB ChB) and have post-graduate experience in one or more areas of clinical medical practice including in medical specialities/disciplines that are relevant to clinical safety and/or to the therapy/disease areas in which the company develops and markets medicines.
Or:
- Qualified healthcare professional or Life Sciences graduate.
Preferred:
They will preferably hold relevant Board Certification(s) or be board eligible, and/or other relevant post-graduate medical qualifications, in relevant areas of clinical medicine.
They will typically possess 4 or more years of clinical drug development experience in the biopharmaceutical industry or a related sector (e.g. academia; CRO; etc). Preferably including at least 2 years of experience in a clinical drug safety-related role.
● 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
● Fluent in Mandarin and English
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.