Associate safety director

PbAssociate Safety Director (m/f/d) (LSW)- Drug safety/pharmacovigilance/ English /b /ppbBackground: /bPortfolio Safety Scientists (PCS-Sci) provide safety science and pharmacovigilance support to /p pmolecules across the Roche portfolio. As a group, they are responsible for all aspects of safety /p pscience/pharmacovigilance, with accountability being held by PCS leadership and experts or SSLs (Safety /p pStrategy Program Leaders) depending on the deliverable/activity. The Portfolio Safety Scientists (PCS-Sci) /p psupports early and late phase development activities as a member of the safety team, providing essential /p psafety oversight and input into all aspects of study management across the entire development and marketed /p pportfolio. In the post-market setting this may include signal evaluation, safety related activities associated with /p pnew drug applications/regulatory filings, benefit-risk assessment and safety risk management. The Associate /p pSafety Director will be expected to work with minimal supervision and apply strong self-leadership. The job /p pholder will be expected to complete the required training. /p pbThe Perfect Candidate: /bThe perfect candidate is an Associate Safety Director with at least 4 years of drug /p pdevelopment experience, including a minimum of 3 years in drug safety/pharmacovigilance, and is a qualified /p phealthcare or life sciences professional. This individual must possess the expert understanding required to /p pproactively manage all aspects of product safety, including signal detection, risk /p pmanagement (RMP/CCDS), and complex data analysis, while ensuring all documentation and regulatory /p psubmissions adhere to GxP standards. /p pbTasks Responsibilities: /b /p pDevelop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas. /p pDevelop and maintain an expert understanding of the safety profile of the assigned product(s) as well as /p punderstanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, /p pmechanism of action). /p liResponsible for individual and aggregate case reporting activities including ICSR case management /li p(medical review) and aggregate reporting (i.e. DSUR, PBRER). /p liResponsible for signal detection and management activities. Contribute to the strategy and review of /li psafety assessments and drug safety reports for signals or issues (incl, product quality) or in response to /p pRegulatory Authority requests. /p liProvide expert contribution to the development of the product safety strategy. /li liTake independent responsibility for risk management activities including preparation and maintenance /li pof CCDS, labeling document maintenance (including IB), risk communications, RMP. /p liReview of clinical protocols, study reports, Investigator’s Brochure (IB), informed consent form (ICF) /li pand other related documents to ensure alignment with the safety strategy and ensure the /p pappropriateness of risk management strategies and risk communication. /p liTake responsibility for safety science contributions to regulatory authority submissions (Investigational /li pNew Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization /p pApplications/MAAs, Variations, Renewals, etc.). /p liResponsible for the preparation and maintenance of safety sections of the Company Core Data Sheet /li pand/or Reference Safety Information in the IB. * Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring /p pcommittee (IMC) meetings, as applicable. /p liIn partnership with the SSL, support presentation of important safety issues to the Drug Safety /li pCommittee (DSC), Development Review. Committee (DRC) and other internal and external review and /p pgovernance committees as needed. /p liActs independently to manage safety responsibilities on study teams and in activities supporting /li pclinical safety. /p liTake on the responsibility for specialised roles with PCS. These may include, but are not limited to; /li pfunctional business process owner, subject matter expert. May be expected to support non-molecule /p pprojects, due diligence evaluations and other projects as needed. /p liPerform specialized roles with PCS. These may include, but are not limited to; functional business /li pprocess owner, subject matter expert, safety committee member. /p liResponsible for coordination and collaboration with vendors servicing Safety Science. Understanding /li pof GxP and regulated processes and end to end clinical trial lifecycle. /p pbMust Haves : /b /p liQualified healthcare professional or Life Sciences graduate. Preferred Qualifications: A relevant /li ppostgraduate qualification (e.g. PHD/MSc in a Life sciences discipline; PharmD or other post-graduate /p phealth professional qualifications) would be advantageous. /p liWork Experience 4 or more years of drug development experience in the pharmaceutical or related /li pindustry. /p liAt least 3 years in drug safety/PV or a closely related field /li liMinimum level required Associate Safety Director /li liIT/Tool Skills good excel/word/powerpoint skills; able to extract data from the Safety Database and /li papply complex data analysis /p liLanguage Skills: Fluent in English, both written and verbal /li pbReference Nr.: /b /p pbRole: Associate Safety Director /b /p pbIndustrie: /bPharma /p pbWorkplace: /bBasel /p pbPensum: 100% /b /p pbStart: /b /p pbDuration: 12 months ++ /b /p pbDeadline /b: /p pIf you are binterested /bin this position, please send us your complete dossier. If this position does not fit your /p pprofile and you wish to be considered for another position directly, you can also send us your dossier via this /p pad or to jobs(at)itcag(dot)com. /p pbContact us /bfor more information about our company, our positions or our attractive Payroll-Only programme: /p p . /p pbAbout us /b: ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. /p pITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life /p pScience Engineering.We offer staff leasing payroll services. For our candidates this is free of charge, also for Payroll we do not /p pcharge you any additional fees. /p