(Sr) Safety Scientist/Associate Safety Director — Roche
NewCHF 68'000 - 103'000
Roche · Basel (BS)
- Location
- Basel
- Contract
- full-time
- Posted
- 2 days ago
SalaryCHF 68'000 - 103'000
Role overview
At Roche you can show up as yourself, embraced for the unique qualities you bring.
Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally.
This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come.
- At Roche you can show up as yourself, embraced for the unique qualities you bring.
- Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally.
- 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. (
Main responsibilities
- 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. (
- 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 qualifie
Additional details
- 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.
