Associate Safety Director (m/f/d) (LSW)- Drug safety/pharmacovigilance/ English Background: Portfolio Safety Scientists (PCS-Sci) provide safety science and pharmacovigilance support tomolecules across the Roche portfolio. As a group, they are responsible for all aspects of safetyscience/pharmacovigilance, with accountability being held by PCS leadership and experts or SSLs (SafetyStrategy 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 essentialsafety oversight and input into all aspects of study management across the entire development and marketedportfolio. In the post-market setting this may include signal evaluation, safety related activities associated withnew drug applications/regulatory filings, benefit-risk assessment and safety risk management. The AssociateSafety Director will be expected to work with minimal supervision and apply strong self-leadership. The jobholder will be expected to complete the required training.The Perfect Candidate: The perfect candidate is an Associate Safety Director with at least 4 years of drugdevelopment experience, including a minimum of 3 years in drug safety/pharmacovigilance, and is a qualifiedhealthcare or life sciences professional. This individual must possess the expert understanding required toproactively manage all aspects of product safety, including signal detection, riskmanagement (RMP/CCDS), and complex data analysis, while ensuring all documentation and regulatorysubmissions adhere to GxP standards.Tasks & Responsibilities: 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 asunderstanding of the relevant strategic context (, 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 ( DSUR, PBRER).Responsible for signal detection and management activities. Contribute to the strategy and review ofsafety assessments and drug safety reports for signals or issues (incl, product quality) or in response toRegulatory Authority requests.Provide expert contribution to the development of the product safety strategy.Take independent responsibility for risk management activities including preparation and maintenanceof CCDS, labeling document maintenance (including IB), risk communications, RMP.Review of clinical protocols, study reports, Investigator's Brochure (IB), informed consent form (ICF)and other related documents to ensure alignment with the safety strategy and ensure theappropriateness of risk management strategies and risk communication.Take responsibility for safety science contributions to regulatory authority submissions (InvestigationalNew Drug/IND applications, New Drug Applications/NDAs, Marketing AuthorizationApplications/MAAs, Variations, Renewals, etc.).Responsible for the preparation and maintenance of safety sections of the Company Core Data Sheetand/or Reference Safety Information in the IB.
- Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoringcommittee (IMC) meetings, as applicable.In partnership with the SSL, support presentation of important safety issues to the Drug SafetyCommittee (DSC), Development Review. Committee (DRC) and other internal and external review andgovernance committees as needed.Acts independently to manage safety responsibilities on study teams and in activities supportingclinical safety.Take on the responsibility for specialised roles with PCS. These may include, but are not limited to; functional business process owner, subject matter expert. May be expected to support non-moleculeprojects, due diligence evaluations and other projects as needed.Perform specialized roles with PCS. These may include, but are not limited to; functional businessprocess owner, subject matter expert, safety committee member.Responsible for coordination and collaboration with vendors servicing Safety Science. Understandingof GxP and regulated processes and end to end clinical trial lifecycleMust Haves : Qualified healthcare professional or Life Sciences graduate. Preferred Qualification j4id10258151a j4it0625a j4iy26a