Tasks & Responsibilities:
Über den Job
<div class="listed-role panel bg-white bg-shadow mr-md-4"><div class="type">temporary</div><p><strong>Associate Safety Director (m/f/d) (LSW)- Drug safety/pharmacovigilance/ English </strong></p><p><strong>Background: </strong>Portfolio Safety Scientists (PCS-Sci) provide safety science and pharmacovigilance support to</p><p>molecules across the Roche portfolio. As a group, they are responsible for all aspects of safety</p><p>science/pharmacovigilance, with accountability being held by PCS leadership and experts or SSLs (Safety</p><p>Strategy Program Leaders) depending on the deliverable/activity. The Portfolio Safety Scientists (PCS-Sci)</p><p>supports early and late phase development activities as a member of the safety team, providing essential</p><p>safety oversight and input into all aspects of study management across the entire development and marketed</p><p>portfolio. In the post-market setting this may include signal evaluation, safety related activities associated with</p><p>new drug applications/regulatory filings, benefit-risk assessment and safety risk management. The Associate</p><p>Safety Director will be expected to work with minimal supervision and apply strong self-leadership. The job</p><p>holder will be expected to complete the required training.</p><p></p><p><strong>The Perfect Candidate: </strong>The perfect candidate is an Associate Safety Director with at least 4 years of drug</p><p>development experience, including a minimum of 3 years in drug safety/pharmacovigilance, and is a qualified</p><p>healthcare or life sciences professional. This individual must possess the expert understanding required to</p><p>proactively manage all aspects of product safety, including signal detection, risk</p><p>management (RMP/CCDS), and complex data analysis, while ensuring all documentation and regulatory</p><p>submissions adhere to GxP standards.</p><p></p><p><strong>Tasks & Responsibilities: </strong></p><p>Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas.</p><p>Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as</p><p>understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors,</p><p>mechanism of action).</p><ul><li>Responsible for individual and aggregate case reporting activities including ICSR case management</li></ul><p>(medical review) and aggregate reporting (i.e. DSUR, PBRER).</p><ul><li>Responsible for signal detection and management activities. Contribute to the strategy and review of</li></ul><p>safety assessments and drug safety reports for signals or issues (incl, product quality) or in response to</p><p>Regulatory Authority requests.</p><ul><li>Provide expert contribution to the development of the product safety strategy.</li><li>Take independent responsibility for risk management activities including preparation and maintenance</li></ul><p>of CCDS, labeling document maintenance (including IB), risk communications, RMP.</p><ul><li>Review of clinical protocols, study reports, Investigator’s Brochure (IB), informed consent form (ICF)</li></ul><p>and other related documents to ensure alignment with the safety strategy and ensure the</p><p>appropriateness of risk management strategies and risk communication.</p><ul><li>Take responsibility for safety science contributions to regulatory authority submissions (Investigational</li></ul><p>New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization</p><p>Applications/MAAs, Variations, Renewals, etc.).</p><ul><li>Responsible for the preparation and maintenance of safety sections of the Company Core Data Sheet</li></ul><p>and/or Reference Safety Information in the IB. * Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring</p><p>committee (IMC) meetings, as applicable.</p><ul><li>In partnership with the SSL, support presentation of important safety issues to the Drug Safety</li></ul><p>Committee (DSC), Development Review. Committee (DRC) and other internal and external review and</p><p>governance committees as needed.</p><ul><li>Acts independently to manage safety responsibilities on study teams and in activities supporting</li></ul><p>clinical safety.</p><ul><li>Take on the responsibility for specialised roles with PCS. These may include, but are not limited to;</li></ul><p>functional business process owner, subject matter expert. May be expected to support non-molecule</p><p>projects, due diligence evaluations and other projects as needed.</p><ul><li>Perform specialized roles with PCS. These may include, but are not limited to; functional business</li></ul><p>process owner, subject matter expert, safety committee member.</p><ul><li>Responsible for coordination and collaboration with vendors servicing Safety Science. Understanding</li></ul><p>of GxP and regulated processes and end to end clinical trial lifecycle.</p><p></p><p><strong>Must Haves : </strong></p><ul><li>Qualified healthcare professional or Life Sciences graduate. Preferred Qualifications: A relevant</li></ul><p>postgraduate qualification (e.g. PHD/MSc in a Life sciences discipline; PharmD or other post-graduate</p><p>health professional qualifications) would be advantageous.</p><ul><li>Work Experience 4 or more years of drug development experience in the pharmaceutical or related</li></ul><p>industry.</p><ul><li>At least 3 years in drug safety/PV or a closely related field</li><li>Minimum level required Associate Safety Director</li><li>IT/Tool Skills good excel/word/powerpoint skills; able to extract data from the Safety Database and</li></ul><p>apply complex data analysis</p><ul><li>Language Skills: Fluent in English, both written and verbal</li><li></li></ul><p><strong>Reference Nr.: </strong>925025</p><p><strong>Role: Associate Safety Director </strong></p><p><strong>Industrie: </strong>Pharma</p><p><strong>Workplace: </strong>Basel</p><p><strong>Pensum: 100% </strong></p><p><strong>Start: </strong>21.08.2026</p><p><strong>Duration: 12 months ++ </strong></p><p><strong>Deadline </strong>:24.06.2026</p><p></p><p>If you are <strong>interested </strong>in this position, please send us your complete dossier. If this position does not fit your</p><p>profile and you wish to be considered for another position directly, you can also send us your dossier via this</p><p>ad or to jobs[at]itcag[dot]com.</p><p><strong>Contact us </strong>for more information about our company, our positions or our attractive Payroll-Only programme:</p><p>+41 41 760 77 01.</p><p><strong>About us</strong>: ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland.</p><p>ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life</p><p>Science & Engineering.We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not</p><p>charge you any additional fees.</p><p><img class="lazyload" data-src="https://counter.adcourier.com/Z29waS41NzgzMC4xMjMzOUBpdGVjaC5hcGxpdHJhay5jb20.gif" src="data:image/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw=="/><noscript><img src="https://counter.adcourier.com/Z29waS41NzgzMC4xMjMzOUBpdGVjaC5hcGxpdHJhay5jb20.gif"/></noscript></p><a class="wpbb-application-url" href="https://www.aplitrak.com/?adid=Z29waS41NzgzMC4xMjMzOUBpdGVjaC5hcGxpdHJhay5jb20" target="_blank">Apply Now</a> </div>
