{"id":5981,"date":"2026-06-17T17:55:59","date_gmt":"2026-06-17T15:55:59","guid":{"rendered":"https:\/\/www.itcag.com\/chen\/jobs\/associate-safety-director-8152\/"},"modified":"2026-06-17T17:55:59","modified_gmt":"2026-06-17T15:55:59","slug":"associate-safety-director-5981","status":"publish","type":"wpbb_job","link":"https:\/\/www.itcag.com\/chen\/jobs\/associate-safety-director-5981\/","title":{"rendered":"Associate Safety Director"},"content":{"rendered":"<p><strong>Associate Safety Director (m\/f\/d) (LSW)- Drug safety\/pharmacovigilance\/ English <\/strong><\/p>\n<p><strong>Background: <\/strong>Portfolio Safety Scientists (PCS-Sci) provide safety science and pharmacovigilance support to<\/p>\n<p>molecules across the Roche portfolio. As a group, they are responsible for all aspects of safety<\/p>\n<p>science\/pharmacovigilance, with accountability being held by PCS leadership and experts or SSLs (Safety<\/p>\n<p>Strategy Program Leaders) depending on the deliverable\/activity. The Portfolio Safety Scientists (PCS-Sci)<\/p>\n<p>supports early and late phase development activities as a member of the safety team, providing essential<\/p>\n<p>safety oversight and input into all aspects of study management across the entire development and marketed<\/p>\n<p>portfolio. In the post-market setting this may include signal evaluation, safety related activities associated with<\/p>\n<p>new drug applications\/regulatory filings, benefit-risk assessment and safety risk management. The Associate<\/p>\n<p>Safety Director will be expected to work with minimal supervision and apply strong self-leadership. The job<\/p>\n<p>holder will be expected to complete the required training.<\/p>\n<\/p>\n<p><strong>The Perfect Candidate: <\/strong>The perfect candidate is an Associate Safety Director with at least 4 years of drug<\/p>\n<p>development experience, including a minimum of 3 years in drug safety\/pharmacovigilance, and is a qualified<\/p>\n<p>healthcare or life sciences professional. This individual must possess the expert understanding required to<\/p>\n<p>proactively manage all aspects of product safety, including signal detection, risk<\/p>\n<p>management (RMP\/CCDS), and complex data analysis, while ensuring all documentation and regulatory<\/p>\n<p>submissions adhere to GxP standards.<\/p>\n<\/p>\n<p><strong>Tasks &amp; Responsibilities: <\/strong><\/p>\n<p>Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas.<\/p>\n<p>Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as<\/p>\n<p>understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors,<\/p>\n<p>mechanism of action).<\/p>\n<ul>\n<li>Responsible for individual and aggregate case reporting activities including ICSR case management<\/li>\n<\/ul>\n<p>(medical review) and aggregate reporting (i.e. DSUR, PBRER).<\/p>\n<ul>\n<li>Responsible for signal detection and management activities. Contribute to the strategy and review of<\/li>\n<\/ul>\n<p>safety assessments and drug safety reports for signals or issues (incl, product quality) or in response to<\/p>\n<p>Regulatory Authority requests.<\/p>\n<ul>\n<li>Provide expert contribution to the development of the product safety strategy.<\/li>\n<li>Take independent responsibility for risk management activities including preparation and maintenance<\/li>\n<\/ul>\n<p>of CCDS, labeling document maintenance (including IB), risk communications, RMP.<\/p>\n<ul>\n<li>Review of clinical protocols, study reports, Investigator&#8217;s Brochure (IB), informed consent form (ICF)<\/li>\n<\/ul>\n<p>and other related documents to ensure alignment with the safety strategy and ensure the<\/p>\n<p>appropriateness of risk management strategies and risk communication.<\/p>\n<ul>\n<li>Take responsibility for safety science contributions to regulatory authority submissions (Investigational<\/li>\n<\/ul>\n<p>New Drug\/IND applications, New Drug Applications\/NDAs, Marketing Authorization<\/p>\n<p>Applications\/MAAs, Variations, Renewals, etc.).<\/p>\n<ul>\n<li>Responsible for the preparation and maintenance of safety sections of the Company Core Data Sheet<\/li>\n<\/ul>\n<p>and\/or Reference Safety Information in the IB. * Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring<\/p>\n<p>committee (IMC) meetings, as applicable.<\/p>\n<ul>\n<li>In partnership with the SSL, support presentation of important safety issues to the Drug Safety<\/li>\n<\/ul>\n<p>Committee (DSC), Development Review. Committee (DRC) and other internal and external review and<\/p>\n<p>governance committees as needed.<\/p>\n<ul>\n<li>Acts independently to manage safety responsibilities on study teams and in activities supporting<\/li>\n<\/ul>\n<p>clinical safety.<\/p>\n<ul>\n<li>Take on the responsibility for specialised roles with PCS. These may include, but are not limited to;<\/li>\n<\/ul>\n<p>functional business process owner, subject matter expert. May be expected to support non-molecule<\/p>\n<p>projects, due diligence evaluations and other projects as needed.<\/p>\n<ul>\n<li>Perform specialized roles with PCS. These may include, but are not limited to; functional business<\/li>\n<\/ul>\n<p>process owner, subject matter expert, safety committee member.<\/p>\n<ul>\n<li>Responsible for coordination and collaboration with vendors servicing Safety Science. Understanding<\/li>\n<\/ul>\n<p>of GxP and regulated processes and end to end clinical trial lifecycle.<\/p>\n<\/p>\n<p><strong>Must Haves : <\/strong><\/p>\n<ul>\n<li>Qualified healthcare professional or Life Sciences graduate. Preferred Qualifications: A relevant<\/li>\n<\/ul>\n<p>postgraduate qualification (e.g. PHD\/MSc in a Life sciences discipline; PharmD or other post-graduate<\/p>\n<p>health professional qualifications) would be advantageous.<\/p>\n<ul>\n<li>Work Experience 4 or more years of drug development experience in the pharmaceutical or related<\/li>\n<\/ul>\n<p>industry.<\/p>\n<ul>\n<li>At least 3 years in drug safety\/PV or a closely related field<\/li>\n<li>Minimum level required Associate Safety Director<\/li>\n<li>IT\/Tool Skills good excel\/word\/powerpoint skills; able to extract data from the Safety Database and<\/li>\n<\/ul>\n<p>apply complex data analysis<\/p>\n<ul>\n<li>Language Skills: Fluent in English, both written and verbal<\/li>\n<li><\/li>\n<\/ul>\n<p><strong>Reference Nr.: <\/strong>925025<\/p>\n<p><strong>Role: Associate Safety Director <\/strong><\/p>\n<p><strong>Industrie: <\/strong>Pharma<\/p>\n<p><strong>Workplace: <\/strong>Basel<\/p>\n<p><strong>Pensum: 100% <\/strong><\/p>\n<p><strong>Start: <\/strong>21.08.2026<\/p>\n<p><strong>Duration: 12 months ++ <\/strong><\/p>\n<p><strong>Deadline <\/strong>:24.06.2026<\/p>\n<\/p>\n<p>If you are <strong>interested <\/strong>in this position, please send us your complete dossier. If this position does not fit your<\/p>\n<p>profile and you wish to be considered for another position directly, you can also send us your dossier via this<\/p>\n<p>ad or to jobs[at]itcag[dot]com.<\/p>\n<p><strong>Contact us <\/strong>for more information about our company, our positions or our attractive Payroll-Only programme:<\/p>\n<p>+41 41 760 77 01.<\/p>\n<p><strong>About us<\/strong>: ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland.<\/p>\n<p>ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life<\/p>\n<p>Science &amp; Engineering.We offer staff leasing &amp; payroll services. For our candidates this is free of charge, also for Payroll we do not<\/p>\n<p>charge you any additional fees.<\/p>\n<p><img src=\"https:\/\/counter.adcourier.com\/Z29waS41NzgzMC4xMjMzOUBpdGVjaC5hcGxpdHJhay5jb20.gif\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Associate Safety Director (m\/f\/d) (LSW)- Drug safety\/pharmacovigilance\/ English Background: Portfolio Safety Scientists (PCS-Sci) provide safety science and pharmacovigilance support to molecules across the Roche portfolio. As a group, they are responsible for all aspects of safety science\/pharmacovigilance, with accountability being held by PCS leadership and experts or SSLs (Safety Strategy Program Leaders) depending on the [&hellip;]<\/p>\n","protected":false},"author":0,"template":"","wpbb_job_industry":[17],"wpbb_job_location":[6],"wpbb_job_type":[15],"wpbb_job_skill":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v15.3 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Associate Safety Director - Swiss (EN)<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.itcag.com\/chen\/jobs\/associate-safety-director-5981\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Associate Safety Director - Swiss (EN)\" \/>\n<meta property=\"og:description\" content=\"Associate Safety Director (m\/f\/d) (LSW)- Drug safety\/pharmacovigilance\/ English Background: Portfolio Safety Scientists (PCS-Sci) provide safety science and pharmacovigilance support to molecules across the Roche portfolio. As a group, they are responsible for all aspects of safety science\/pharmacovigilance, with accountability being held by PCS leadership and experts or SSLs (Safety Strategy Program Leaders) depending on the [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.itcag.com\/chen\/jobs\/associate-safety-director-5981\/\" \/>\n<meta property=\"og:site_name\" content=\"Swiss (EN)\" \/>\n<meta property=\"og:image\" content=\"https:\/\/counter.adcourier.com\/Z29waS41NzgzMC4xMjMzOUBpdGVjaC5hcGxpdHJhay5jb20.gif\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Estimated reading time\">\n\t<meta name=\"twitter:data1\" content=\"3 minutes\">\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.itcag.com\/chen\/#organization\",\"name\":\"iTech Consult\",\"url\":\"https:\/\/www.itcag.com\/chen\/\",\"sameAs\":[],\"logo\":{\"@type\":\"ImageObject\",\"@id\":\"https:\/\/www.itcag.com\/chen\/#logo\",\"inLanguage\":\"en-GB\",\"url\":\"https:\/\/www.itcag.com\/chen\/wp-content\/uploads\/sites\/2\/2020\/12\/logo.png\",\"width\":400,\"height\":400,\"caption\":\"iTech Consult\"},\"image\":{\"@id\":\"https:\/\/www.itcag.com\/chen\/#logo\"}},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.itcag.com\/chen\/#website\",\"url\":\"https:\/\/www.itcag.com\/chen\/\",\"name\":\"Swiss (EN)\",\"description\":\"Recruitment Agency\",\"publisher\":{\"@id\":\"https:\/\/www.itcag.com\/chen\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":\"https:\/\/www.itcag.com\/chen\/?s={search_term_string}\",\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-GB\"},{\"@type\":\"ImageObject\",\"@id\":\"https:\/\/www.itcag.com\/chen\/jobs\/associate-safety-director-5981\/#primaryimage\",\"inLanguage\":\"en-GB\",\"url\":\"https:\/\/counter.adcourier.com\/Z29waS41NzgzMC4xMjMzOUBpdGVjaC5hcGxpdHJhay5jb20.gif\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.itcag.com\/chen\/jobs\/associate-safety-director-5981\/#webpage\",\"url\":\"https:\/\/www.itcag.com\/chen\/jobs\/associate-safety-director-5981\/\",\"name\":\"Associate Safety Director - Swiss (EN)\",\"isPartOf\":{\"@id\":\"https:\/\/www.itcag.com\/chen\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.itcag.com\/chen\/jobs\/associate-safety-director-5981\/#primaryimage\"},\"datePublished\":\"2026-06-17T15:55:59+00:00\",\"dateModified\":\"2026-06-17T15:55:59+00:00\",\"inLanguage\":\"en-GB\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.itcag.com\/chen\/jobs\/associate-safety-director-5981\/\"]}]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","_links":{"self":[{"href":"https:\/\/www.itcag.com\/chen\/wp-json\/wp\/v2\/wpbb_job\/5981"}],"collection":[{"href":"https:\/\/www.itcag.com\/chen\/wp-json\/wp\/v2\/wpbb_job"}],"about":[{"href":"https:\/\/www.itcag.com\/chen\/wp-json\/wp\/v2\/types\/wpbb_job"}],"wp:attachment":[{"href":"https:\/\/www.itcag.com\/chen\/wp-json\/wp\/v2\/media?parent=5981"}],"wp:term":[{"taxonomy":"wpbb_job_industry","embeddable":true,"href":"https:\/\/www.itcag.com\/chen\/wp-json\/wp\/v2\/wpbb_job_industry?post=5981"},{"taxonomy":"wpbb_job_location","embeddable":true,"href":"https:\/\/www.itcag.com\/chen\/wp-json\/wp\/v2\/wpbb_job_location?post=5981"},{"taxonomy":"wpbb_job_type","embeddable":true,"href":"https:\/\/www.itcag.com\/chen\/wp-json\/wp\/v2\/wpbb_job_type?post=5981"},{"taxonomy":"wpbb_job_skill","embeddable":true,"href":"https:\/\/www.itcag.com\/chen\/wp-json\/wp\/v2\/wpbb_job_skill?post=5981"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}