[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"project-associate-safety-director-mfd-drug-safetypharmacovigilance":3,"similar-associate-safety-director-mfd-drug-safetypharmacovigilance":37,"matching-freelancers-associate-safety-director-mfd-drug-safetypharmacovigilance":302},{"id":4,"slug":5,"title":6,"description":7,"skills":8,"budget":21,"duration":22,"location":23,"onsitePercent":24,"contractType":25,"foundAt":26,"category":27,"rawText":31,"webTitle":32,"webText":33,"language":34,"projectId":35,"sourceUrl":36},13574,"associate-safety-director-mfd-drug-safetypharmacovigilance","Associate Safety Director (m\u002Ff\u002Fd) - Drug Safety\u002FPharmacovigilance","Associate Safety Director mit mindestens 4 Jahren Arzneimittelentwicklung und 3 Jahren Erfahrung in Drug Safety\u002FPharmacovigilance für Portfolio Safety Scientists bei Roche. Verantwortung für Sicherheitsprofil, Signaldetektion, Risikomanagement und regulatorische Einreichungen mit minimaler Aufsicht.",[9,10,11,12,13,14,15,16,17,18,19,20],"Drug Safety","Pharmacovigilance","ICSR case management","Signal detection","Risk management","RMP\u002FCCDS","Regulatory submissions","GxP standards","Clinical trial lifecycle","Excel","Data analysis","English fluency",null,"12 months ++","Basel",100,"temp_work","2026-06-17T15:56:11+00:00",{"id":28,"slug":29,"label":30},14,"medical_tech","Medizintechnik","Associate Safety Director\n\ntemporary\nAssociate Safety Director\nAssociate Safety Director (m\u002Ff\u002Fd) (LSW)- Drug safety\u002Fpharmacovigilance\u002F English\nBackground: Portfolio Safety Scientists (PCS-Sci) provide safety science and pharmacovigilance support to\nmolecules across the Roche portfolio. As a group, they are responsible for all aspects of safety\nscience\u002Fpharmacovigilance, with accountability being held by PCS leadership and experts or SSLs (Safety\nStrategy Program Leaders) depending on the deliverable\u002Factivity. The Portfolio Safety Scientists (PCS-Sci)\nsupports early and late phase development activities as a member of the safety team, providing essential\nsafety oversight and input into all aspects of study management across the entire development and marketed\nportfolio. In the post-market setting this may include signal evaluation, safety related activities associated with\nnew drug applications\u002Fregulatory filings, benefit-risk assessment and safety risk management. The Associate\nSafety Director will be expected to work with minimal supervision and apply strong self-leadership. The job\nholder will be expected to complete the required training.\nThe Perfect Candidate: The perfect candidate is an Associate Safety Director with at least 4 years of drug\ndevelopment experience, including a minimum of 3 years in drug safety\u002Fpharmacovigilance, and is a qualified\nhealthcare or life sciences professional. This individual must possess the expert understanding required to\nproactively manage all aspects of product safety, including signal detection, risk\nmanagement (RMP\u002FCCDS), and complex data analysis, while ensuring all documentation and regulatory\nsubmissions adhere to GxP standards.\nTasks & Responsibilities:\nDevelop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas.\nDevelop and maintain an expert understanding of the safety profile of the assigned product(s) as well as\nunderstanding of the relevant strategic context (e.g., disease under study, safety profile of competitors,\nmechanism of action).\nResponsible for individual and aggregate case reporting activities including ICSR case management\n(medical review) and aggregate reporting (i.e. DSUR, PBRER).\nResponsible for signal detection and management activities. Contribute to the strategy and review of\nsafety assessments and drug safety reports for signals or issues (incl, product quality) or in response to\nRegulatory Authority requests.\nProvide expert contribution to the development of the product safety strategy.\nTake independent responsibility for risk management activities including preparation and maintenance\nof CCDS, labeling document maintenance (including IB), risk communications, RMP.\nReview of clinical protocols, study reports, Investigator’s Brochure (IB), informed consent form (ICF)\nand other related documents to ensure alignment with the safety strategy and ensure the\nappropriateness of risk management strategies and risk communication.\nTake responsibility for safety science contributions to regulatory authority submissions (Investigational\nNew Drug\u002FIND applications, New Drug Applications\u002FNDAs, Marketing Authorization\nApplications\u002FMAAs, Variations, Renewals, etc.).\nResponsible for the preparation and maintenance of safety sections of the Company Core Data Sheet\nand\u002For Reference Safety Information in the IB. * Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring\ncommittee (IMC) meetings, as applicable.\nIn partnership with the SSL, support presentation of important safety issues to the Drug Safety\nCommittee (DSC), Development Review. Committee (DRC) and other internal and external review and\ngovernance committees as needed.\nActs independently to manage safety responsibilities on study teams and in activities supporting\nclinical safety.\nTake on the responsibility for specialised roles with PCS. These may include, but are not limited to;\nfunctional business process owner, subject matter expert. May be expected to support non-molecule\nprojects, due diligence evaluations and other projects as needed.\nPerform specialized roles with PCS. These may include, but are not limited to; functional business\nprocess owner, subject matter expert, safety committee member.\nResponsible for coordination and collaboration with vendors servicing Safety Science. Understanding\nof GxP and regulated processes and end to end clinical trial lifecycle.\nMust Haves :\nQualified healthcare professional or Life Sciences graduate. Preferred Qualifications: A relevant\npostgraduate qualification (e.g. PHD\u002FMSc in a Life sciences discipline; PharmD or other post-graduate\nhealth professional qualifications) would be advantageous.\nWork Experience 4 or more years of drug development experience in the pharmaceutical or related\nindustry.\nAt least 3 years in drug safety\u002FPV or a closely related field\nMinimum level required Associate Safety Director\nIT\u002FTool Skills good excel\u002Fword\u002Fpowerpoint skills; able to extract data from the Safety Database and\napply complex data analysis\nLanguage Skills: Fluent in English, both written and verbal\nReference Nr.: 925025\nRole: Associate Safety Director\nIndustrie: Pharma\nWorkplace: Basel\nPensum: 100%\nStart: 21.08.2026\nDuration: 12 months ++\nDeadline :24.06.2026\nIf you are interested in this position, please send us your complete dossier. If this position does not fit your\nprofile and you wish to be considered for another position directly, you can also send us your dossier via this\nad or to jobs[at]itcag[dot]com.\nContact us for more information about our company, our positions or our attractive Payroll-Only programme:\n+41 41 760 77 01.\nAbout us: ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland.\nITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life\nScience & Engineering.We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not\ncharge you any additional fees.\nApply Now\n\nIndustry\nPharmaceuticals\nLocation\nBasel\nType\ntemporary\n\nE-Mail: service@itcag.com","Associate Safety Director (Drug Safety\u002FPharmacovigilance)","Wir suchen einen erfahrenen Associate Safety Director (m\u002Fw\u002Fd) für unser Portfolio Safety Team. Diese Rolle bietet die Gelegenheit, eine Schlüsselposition in der Arzneimittelsicherheit und Pharmakovigilanz zu übernehmen und dabei minimale Aufsicht bei maximaler Eigenverantwortung zu genießen.\n\nAufgaben und Verantwortung:\nSie entwickeln und pflegen ein umfassendes Verständnis der Sicherheitsprofile zugewiesener Produkte und Therapiebereiche. Sie sind verantwortlich für individuelle und aggregierte Fallmeldungsaktivitäten, einschließlich ICSR-Fallmanagement und aggregierter Berichterstattung (DSUR, PBRER). Ihre Expertise wird in der Signaldetektion und -verwaltung sowie in der Entwicklung von Produktsicherheitsstrategien eingebracht.\n\nSie übernehmen unabhängige Verantwortung für Risikomanagementaktivitäten, einschließlich Vorbereitung und Wartung von Sicherheitsinformationen, Kennzeichnungsdokumenten und Risikokommunikation. Darüber hinaus überprüfen Sie klinische Protokolle, Studienberichte und verwandte Dokumente, um die Einhaltung der Sicherheitsstrategie sicherzustellen.\n\nAnforderungen:\nSie verfügen über mindestens 4 Jahre Erfahrung in der Arzneimittelentwicklung, davon mindestens 3 Jahre in Arzneimittelsicherheit und Pharmakovigilanz. Eine qualifizierte Ausbildung im Gesundheitswesen oder in den Biowissenschaften ist erforderlich. Sie besitzen Expertenwissen in Signaldetektion, Risikomanagement (RMP\u002FCCDS) und komplexer Datenanalyse. Fundierte Kenntnisse von GxP-Standards und regulatorischen Anforderungen sind essentiell.\n\nDiese temporäre Position bietet die Möglichkeit, in einem dynamischen Umfeld Ihre Fachkompetenz unter Beweis zu stellen und an der Sicherheit von Arzneimitteln mitzuwirken.","en","925025","https:\u002F\u002Fwww.itcag.com\u002Fjobs\u002Fassociate-safety-director-8152\u002F",{"items":38},[39,61,80,98,112,133,149,164,183,197,209,225,241,262,283],{"id":40,"slug":41,"title":42,"description":43,"skills":44,"budget":21,"duration":21,"location":57,"onsitePercent":24,"contractType":58,"foundAt":59,"category":60},13720,"mitarbeiter-produktion-support-compliance-mwd","Mitarbeiter Produktion Support Compliance (m\u002Fw\u002Fd)","Unterstützung des betrieblichen SOP-Systems und GMP-Compliance in der Pharmaindustrie. Koordination von Schulungen, Audits und Inspektionen sowie Dokumentation von Produktions- und Verpackungsprozessen. Anforderung: Abgeschlossene Berufsausbildung\u002FStudium im naturwissenschaftlichen oder pharmazeutischen Bereich mit praktischer Erfahrung in GMP-regulierten Umfeldern.",[45,46,47,48,49,50,51,52,53,54,55,56],"GMP","Audits","Dokumentation","SOP","Koordination","Planung","Produktion","MS Office","LOS","TrackWise","Deutsch","Englisch","Biberach, Baden-Württemberg","contracting","2026-06-18T12:25:55+00:00",{"id":28,"slug":29,"label":30},{"id":62,"slug":63,"title":64,"description":65,"skills":66,"budget":21,"duration":75,"location":76,"onsitePercent":77,"contractType":58,"foundAt":78,"category":79},13665,"mes-business-analyst-italian-speaking-pharmaceutical-manufacturing","MES Business Analyst (Italian Speaking) – Pharmaceutical Manufacturing","Darwin Recruitment sucht einen italienischsprachigen MES Business Analyst zur Unterstützung der Gestaltung und Implementierung von Herstellungsprozessen in einer regulierten Produktionsumgebung in der Pharmaindustrie. Die Position ist auf 6 Monate befristet und erfordert 3-4 Tage pro Woche vor Ort in Rom.",[67,68,69,70,71,72,73,74],"MES Business Analysis","Italian language (native or fluent)","Pharmaceutical manufacturing","Industrial manufacturing","Stakeholder engagement","Requirements gathering","Manufacturing process design","Business process implementation","6 Months","Rome",75,"2026-06-18T10:21:22+00:00",{"id":28,"slug":29,"label":30},{"id":81,"slug":82,"title":83,"description":84,"skills":85,"budget":21,"duration":93,"location":94,"onsitePercent":95,"contractType":58,"foundAt":96,"category":97},13581,"senior-analytical-scientist-hplcuhplc-biologics-3","Senior Analytical Scientist (HPLC\u002FUHPLC, Biologics)","Für ein führendes Pharmaunternehmen wird ein erfahrener Senior Analytical Scientist zur Entwicklung analytischer Methoden von Grund auf für proteinbasierte Produkte in klinischer Phase gesucht. Die Rolle erfordert eigenständiges Arbeiten und fundierte Erfahrung in HPLC\u002FUHPLC-Methodenentwicklung für Biologics. Einsatz in Österreich hybrid mit Laborarbeit vor Ort, ca. 9 Monate ab Mai\u002FJuni 2026.",[86,87,88,89,90,91,92],"Analytische Methodenentwicklung","HPLC\u002FUHPLC","Chromatographie (SEC, RP)","Biologics\u002Fproteinbasierte Produkte","Proteinbiochemie","Thermo Fisher UHPLC-Systeme","Chromeleon Software","ca. 9 Monate, Start Mai\u002FJuni 2026","Österreich",50,"2026-06-17T16:45:57+00:00",{"id":28,"slug":29,"label":30},{"id":99,"slug":100,"title":101,"description":102,"skills":103,"budget":21,"duration":21,"location":108,"onsitePercent":24,"contractType":109,"foundAt":110,"category":111},13343,"projektmanager-pharma-mwd","Projektmanager Pharma (m\u002Fw\u002Fd)","Planung und Leitung von internen Projekten im Pharma-Produktionsumfeld mit Fokus auf In-Vitro Diagnostika. Überführung von Neuprodukten aus der Entwicklung in die Produktion sowie Analyse und Bewertung von Projektrisiken.",[104,105,51,106,47,50,107,56,55],"Projektmanagement","Pharma","Analyse","Kommunikation","Marburg","permanent","2026-06-17T02:26:08+00:00",{"id":28,"slug":29,"label":30},{"id":113,"slug":114,"title":115,"description":116,"skills":117,"budget":21,"duration":130,"location":23,"onsitePercent":24,"contractType":109,"foundAt":131,"category":132},13205,"global-quality-manager-mfd","Global Quality Manager (m\u002Ff\u002Fd)","Für ein großes Pharmaunternehmen in Basel wird ein hochqualifizierter Global Quality Manager gesucht, der als Delegate des Swiss Responsible Person fungiert und Global QA Oversight über das gesamte IMP Distribution Network wahrnimmt. Die Position erfordert umfangreiche Erfahrung in Quality Assurance, GMP\u002FGDP-Compliance und regulatorischer Dokumentation. Der Kandidat wird Deviation Management, Inspection Management und Quality Decision-Making für klinische Studien verantworten.",[118,119,120,121,122,123,124,20,125,126,127,128,129],"Quality Assurance","GMP\u002FGDP","Regulatory Compliance","Deviation Management","CAPA","Inspection Management","Clinical Trial Management","German (asset)","Master Quality Agreements","Complaint Management","Good Documentation Practices","Veeva Vault QMS (nice to have)","12+ Monate","2026-06-16T13:06:18+00:00",{"id":28,"slug":29,"label":30},{"id":134,"slug":135,"title":136,"description":137,"skills":138,"budget":21,"duration":21,"location":146,"onsitePercent":24,"contractType":58,"foundAt":147,"category":148},13001,"chemielaborant-rd-mwd","Chemielaborant R&D (m\u002Fw\u002Fd)","Durchführung von Laborversuchen zur Entwicklung und Optimierung von Rezepturen in der Bauchemie. Selbstständige Planung und Durchführung von Versuchsreihen, Dokumentation von Ergebnissen und Bedienung von Laborgeräten. Enge Zusammenarbeit mit Produktion, Qualität und Anwendungstechnik.",[139,140,141,142,47,143,144,145,56],"Chemielaborant","Laborversuche","Analyseverfahren","Instrumentelle Analytik","Kalibrierung","Laborsoftware","Arbeitssicherheit","Bielefeld","2026-06-15T15:27:41+00:00",{"id":28,"slug":29,"label":30},{"id":150,"slug":151,"title":152,"description":153,"skills":154,"budget":21,"duration":21,"location":57,"onsitePercent":95,"contractType":58,"foundAt":162,"category":163},13000,"junior-systems-specialist-pharma-mwd","Junior Systems Specialist Pharma (m\u002Fw\u002Fd)","Mitarbeit in internationalen IT-Projektteams mit Teilverantwortung als Projektleiter:in für Digitalisierungsprojekte in der Pharmabranche. Betreuung komplexer IT-Systeme im GMP-Umfeld, Fehleranalyse und Datenanalyse mit Python\u002FR zur Unterstützung der Arzneimittelentwicklung.",[155,156,157,45,158,159,160,161],"Python","R","Datenanalyse","IT-Projektmanagement","Fehleranalyse","KI-Tools","Statistik","2026-06-15T15:27:31+00:00",{"id":28,"slug":29,"label":30},{"id":165,"slug":166,"title":167,"description":168,"skills":169,"budget":21,"duration":21,"location":180,"onsitePercent":24,"contractType":109,"foundAt":181,"category":182},12988,"global-product-manager-mwd-tracheostomie","Global Product Manager (m\u002Fw\u002Fd) Tracheostomie","Unterstütze als Global Product Manager ein MedTech-Unternehmen bei der Verantwortung für das globale Tracheostomie-Portfolio. Analysiere und steuere Portfolio- und Pipeline-Daten, führe Markt- und Wettbewerbsanalysen durch und leite internationale Projekte. Entwickle Risikominimierungsmaßnahmen, erstelle Business Cases und identifiziere Effizienzpotenziale.",[170,171,18,172,104,173,174,175,176,177,52,178,179],"Portfoliomanagement","Produktmanagement","Power BI","Scrum","Prince2","Lean","Stakeholder-Management","Regulatorische Anforderungen","Wettbewerbsanalysen","Business Case Entwicklung","Mainz","2026-06-15T15:25:58+00:00",{"id":28,"slug":29,"label":30},{"id":184,"slug":185,"title":186,"description":187,"skills":188,"budget":21,"duration":21,"location":57,"onsitePercent":95,"contractType":58,"foundAt":195,"category":196},12945,"product-lifecycle-expert-packaging-labelling-mwd","Product Lifecycle Expert (Packaging\u002F Labelling) (m\u002Fw\u002Fd)","Koordination von Verpackungs- und Etikettierungsprozessen für klinische Prüfpräparate bei internationalen Lohnherstellern. Bearbeitung und Koordination von Prozessen mit Lohnherstellern und internen Schnittstellen sowie Überprüfung der Herstelldokumentation. Erarbeitung von Verbesserungsvorschlägen zur Risikominimierung und Prozessoptimierung.",[189,190,191,104,192,193,194,55,56],"Pharmaindustrie","Verpackung","Kennzeichnung","Supply Chain Management","MS-Office","Prozessoptimierung","2026-06-15T13:26:07+00:00",{"id":28,"slug":29,"label":30},{"id":198,"slug":199,"title":200,"description":201,"skills":202,"budget":21,"duration":21,"location":57,"onsitePercent":95,"contractType":58,"foundAt":207,"category":208},12942,"technische-assistenz-chromatographie-mwd","Technische Assistenz Chromatographie (m\u002Fw\u002Fd)","Selbstständige Planung, Durchführung und Auswertung von Produkt-Projektarbeitspaketen im Bereich chromatographischer Verfahren. Eigenverantwortliche Bewertung und statistische Analyse mit GMP-Dokumentation. Anwendung analytischer Chromatographie-Kenntnisse unter Qualitätsanforderungen.",[203,204,45,205,47,206,50,49],"Chromatographie","Qualitätskontrolle","Analytische Chemie","Statistische Analyse","2026-06-15T13:25:38+00:00",{"id":28,"slug":29,"label":30},{"id":210,"slug":211,"title":212,"description":213,"skills":214,"budget":21,"duration":21,"location":222,"onsitePercent":95,"contractType":58,"foundAt":223,"category":224},12895,"key-user-lims-qc-experte-gmp-digitalisierung-mwd","Key User LIMS \u002F QC Experte GMP Digitalisierung (m\u002Fw\u002Fd)","Unterstützung von QC-Laboren bei der Evaluierung, Implementierung und Optimierung digitaler Prozesse sowie Implementierung und Administration eines LIMS-Systems unter GMP-Anforderungen. Verantwortung für Masterdatenmanagement, Datenanalyse und Schulungen im Bereich digitale Lösungen.",[215,216,45,217,218,219,52,220,104,157,221,47,194],"LIMS-Systeme","LabWare","GxP","QC-Labor","SAP","Excel VBA","CSV","Frankfurt, Hessen","2026-06-15T11:26:09+00:00",{"id":28,"slug":29,"label":30},{"id":226,"slug":227,"title":228,"description":229,"skills":230,"budget":21,"duration":21,"location":238,"onsitePercent":24,"contractType":109,"foundAt":239,"category":240},12894,"account-manager-fuer-medizintechnik-mwd","Account Manager für Medizintechnik (m\u002Fw\u002Fd)","Account Manager für Medizintechnik mit Fokus auf Betreuung und strategischer Ausbau von Bestandskunden im EMEA-Raum sowie Neukundenakquise. Analyse kundenspezifischer Anforderungen und Positionierung von Produkten in regulierten Anwendungsfeldern. Durchführung von Marktanalysen, Teilnahme an Fachmessen und Projektbegleitung bis zum Vertragsabschluss.",[231,106,232,233,234,235,236,30,237,56,55],"Akquise","Angebotserstellung","Feinwerktechnik","Kommunikationsfähigkeit","Marktanalysen","Maschinenbau","Vertrieb","Würzburg, Bayern","2026-06-15T11:26:01+00:00",{"id":28,"slug":29,"label":30},{"id":242,"slug":243,"title":244,"description":245,"skills":246,"budget":21,"duration":21,"location":259,"onsitePercent":95,"contractType":58,"foundAt":260,"category":261},12893,"clinical-data-manager-clinical-data-management-spezialist-mwd","Clinical Data Manager \u002F Clinical Data Management Spezialist (m\u002Fw\u002Fd)","Gesucht wird ein Clinical Data Manager für ein Hybrid-Projekt in Frankfurt. Aufgaben umfassen Definition von Data-Management-Prozessen, Koordination von User Acceptance Tests für eCRF-Systeme, Planung elektronischer Datentransfers und Überwachung der medizinischen Kodierung. Erforderlich sind ein Masterstudium, mindestens 3 Jahre Berufserfahrung im Clinical Data Management, EDC-Kenntnisse und SAS-Erfahrung.",[247,248,249,250,251,252,253,254,255,104,52,56,256,257,258],"Clinical Data Management","EDC-Systeme","SAS","CDISC","ICH","GCP","FDA","Data Validation","Datenbank","eCRF","MedDRA","WHO-DD","Frankfurt","2026-06-15T11:25:54+00:00",{"id":28,"slug":29,"label":30},{"id":263,"slug":264,"title":265,"description":266,"skills":267,"budget":21,"duration":21,"location":280,"onsitePercent":24,"contractType":58,"foundAt":281,"category":282},12892,"qualifizierungsingenieur-reinraum-hvac-gmp-mwd","Qualifizierungsingenieur Reinraum \u002F HVAC GMP (m\u002Fw\u002Fd)","Durchführung von Qualifizierungen und Validierungen in Reinräumen gemäß GMP-Richtlinien. Überwachung und Dokumentation von Lüftungs- und Klimaanlagen (HVAC) im regulierten Umfeld. Erstellung von Prüfplänen sowie Qualifizierungsdokumentationen (DQ, IQ, OQ, PQ).",[268,269,270,271,272,273,274,275,276,52,277,278,279],"Qualifizierung Reinräume","ISO 14644","GMP-Richtlinien","HVAC","Lüftungs- und Klimaanlagen","DQ\u002FIQ\u002FOQ\u002FPQ","Technische Dokumentation","Median Software","CAQ-Systeme","Prüftechnik","Verfahrenstechnik","Gebäudetechnik","Ingelheim am Rhein, Rheinland-Pfalz","2026-06-15T11:25:46+00:00",{"id":28,"slug":29,"label":30},{"id":284,"slug":285,"title":286,"description":287,"skills":288,"budget":21,"duration":298,"location":299,"onsitePercent":24,"contractType":58,"foundAt":300,"category":301},12876,"freelance-clinical-research-associate-cra-oncology","Freelance Clinical Research Associate (CRA) - Oncology","Erfahrener Clinical Research Associate für zwei parallele Onkologie-Studien (Vexas-Syndrom und Brustkrebs) in Deutschland gesucht. Aufgaben umfassen Site-Visits, Protokoll-Compliance, Datenüberprüfung und Stakeholder-Management. 16 Monate, 0,8 FTE, Start Juni\u002FJuli 2025.",[289,290,291,292,293,294,295,296,297],"Clinical Research Associate (CRA)","Oncology experience","GCP knowledge","Monitoring discipline","Database management","Data review","German language","English language","Protocol compliance","16 months, 0.8 FTE, Start June\u002FJuly 2025","Germany","2026-06-15T10:55:53+00:00",{"id":28,"slug":29,"label":30},{"items":303},[]]