3 jobs found in Basel-Stadt

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    • basel, basel-stadt
    • contract
    Randstad Professionals is looking for an Associate Director, Signal Management for a major client. This position will be based in Basel .Startdate: ASAP (up to 3 month notice period possible)Contract: 12 monthsThis position will have a high degree of visibility and impact across the organization and will collaborate closely cross-functionally and cross-regionally. Your responsibilities:Provide dynamic strategic contribution to the direction and senior leaders of key pharmacovigilance activities across portfolio and throughout the clinical development and post-marketing phases of the life cycle including: Lead all signal management activities for assigned product(s)  Support implantation of signal detection strategy approved by VP of Pharmacovigilance  Review adverse event data, literature and other safety-related data for the purpose of signal detection  Collaborate with Clinical Safety and Risk Management (CSRM) physicians, safety scientists, and medical colleagues to review safety data for signal validation, prioritization, assessment and proposed action plans Partner with the Director, Pharmacovigilance – Signal Management to oversee digital signal detection and management tool.  Serve as an administrator of the tool  Propose and implement signal detection methods in the tool  Train, mentor and assist CSRM staff in using the tool.  Oversee signal tracking and signal notifications to external stakeholders  Generate periodic signal management compliance metrics Provide safety contents for risk management plans and periodic aggregate safety reports, including but not limited to PBRER/PSUR, PADER, DSUR, and IND annual reports in collaboration with Clinical Safety and Risk Management (CSRM) physicians, safety scientists, and medical colleagues Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues  Reviews applicable regulatory intelligence on global regulations/guidance documents and be able to advise report project teams as a Subject Matter Expert (SME) for signal management.  Understand relationships and dependencies between signal management and documents/analyses produced for regulators across the development of RMPs, DSURs, PBRERs, and other annual reports and/or deliverables  Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission  Provide project teams with expertise and strategic guidance on analysis and presentation of safety data and on benefit-risk assessment in documents  Produce high quality, accurate, and fit-for-purpose evaluation documents with clear conclusions, in response to internal or regulatory authority request for safety reasons  Review the worldwide medical/scientific literature to identify signals and applicable information for inclusion in aggregate safety reports in collaboration with CSRM colleagues  Draft regulatory response documents such as PRAC assessment reports  Draft other medical writing deliverables as needed If you are interested to take on these responsibilities you should have the following requirements:Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background  Minimum 8 years relevant medical, scientific/clinical, or pharmaceutical experience, including at least 5 years’ experience in Pharmacovigilance  Excellent written and verbal communication skills with the ability to interpret and present safety data  Knowledge of FDA and EMA regulations, ICH guidelines, Good Clinical Practices, and the drug development process  Knowledge of drug safety/pharmacovigilance practices and tools  Ability to coordinate and prioritize multiple projects in a fast-paced environment with limited to little supervision  Background in vaccines is a plus  Demonstrated ability to develop, execute and follow-through complex projects to completion  Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view  Independently motivated, detail oriented and strong problem-solving ability  Excellent organizational skills and demonstrated ability to multitask in a fast-paced environment with changing priorities  Excellent written and verbal communication skills with the ability to interact across multiple functions Did we spark your interest? We look forward to receiving your online application. Please note a Swiss Work permit is mandatory and your residence needs to be in Switzerland for this position. 
    Randstad Professionals is looking for an Associate Director, Signal Management for a major client. This position will be based in Basel .Startdate: ASAP (up to 3 month notice period possible)Contract: 12 monthsThis position will have a high degree of visibility and impact across the organization and will collaborate closely cross-functionally and cross-regionally. Your responsibilities:Provide dynamic strategic contribution to the direction and senior leaders of key pharmacovigilance activities across portfolio and throughout the clinical development and post-marketing phases of the life cycle including: Lead all signal management activities for assigned product(s)  Support implantation of signal detection strategy approved by VP of Pharmacovigilance  Review adverse event data, literature and other safety-related data for the purpose of signal detection  Collaborate with Clinical Safety and Risk Management (CSRM) physicians, safety scientists, and medical colleagues to review safety data for signal validation, prioritization, assessment and proposed action plans Partner with the Director, Pharmacovigilance – Signal Management to oversee digital signal detection and management tool.  Serve as an administrator of the tool  Propose and implement signal detection methods in the tool  Train, mentor and assist CSRM staff in using the tool.  Oversee signal tracking and signal notifications to external stakeholders  Generate periodic signal management compliance metrics Provide safety contents for risk management plans and periodic aggregate safety reports, including but not limited to PBRER/PSUR, PADER, DSUR, and IND annual reports in collaboration with Clinical Safety and Risk Management (CSRM) physicians, safety scientists, and medical colleagues Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues  Reviews applicable regulatory intelligence on global regulations/guidance documents and be able to advise report project teams as a Subject Matter Expert (SME) for signal management.  Understand relationships and dependencies between signal management and documents/analyses produced for regulators across the development of RMPs, DSURs, PBRERs, and other annual reports and/or deliverables  Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission  Provide project teams with expertise and strategic guidance on analysis and presentation of safety data and on benefit-risk assessment in documents  Produce high quality, accurate, and fit-for-purpose evaluation documents with clear conclusions, in response to internal or regulatory authority request for safety reasons  Review the worldwide medical/scientific literature to identify signals and applicable information for inclusion in aggregate safety reports in collaboration with CSRM colleagues  Draft regulatory response documents such as PRAC assessment reports  Draft other medical writing deliverables as needed If you are interested to take on these responsibilities you should have the following requirements:Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background  Minimum 8 years relevant medical, scientific/clinical, or pharmaceutical experience, including at least 5 years’ experience in Pharmacovigilance  Excellent written and verbal communication skills with the ability to interpret and present safety data  Knowledge of FDA and EMA regulations, ICH guidelines, Good Clinical Practices, and the drug development process  Knowledge of drug safety/pharmacovigilance practices and tools  Ability to coordinate and prioritize multiple projects in a fast-paced environment with limited to little supervision  Background in vaccines is a plus  Demonstrated ability to develop, execute and follow-through complex projects to completion  Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view  Independently motivated, detail oriented and strong problem-solving ability  Excellent organizational skills and demonstrated ability to multitask in a fast-paced environment with changing priorities  Excellent written and verbal communication skills with the ability to interact across multiple functions Did we spark your interest? We look forward to receiving your online application. Please note a Swiss Work permit is mandatory and your residence needs to be in Switzerland for this position. 
    • basel, basel-stadt
    • contract
    Das Department Technische Compliance ist auf der Suche nach einem/r Compliance Experte (m/w/d) für die Betreuung & Implementierung von Qualitätssystemen innerhalb des Engineerings & Energiebetrieben/Werkstätten. Allgemeine Informationen: • Startdatum: asap• Spätestmögliches Startdatum: 01.11.2021• Enddatum: Jahresvertrag• Verlängerung: Wahrscheinlich• Workload: 80-100%• Home Office: nach Absprache zeitweise möglich  Aufgaben & Verantwortlichkeiten: • Unterstützung interner Kunden als anerkannter Berater in sämtlichen technischen GMP Fragestellungen, z.B. Umsetzung von Qualifizierungsanforderungen• Monitoring von Key Performance Indices und Fälligkeiten• Business Process Support für Risk-, Deviation-, Change- und CAPA-Management in enger Kollaboration mit den Qualitätsorganisationen am Standort• Inspektionssupport für den Bereich Technik, Kontakt zu den Subject Matter Experts• Unterstützung und aktive Mitarbeit in agilen Organisationsformen• Unterstützung im Records-Management Must Haves: • Abgeschlossenes technisches Studium oder vergleichbare Ausbildung mit langjähriger Berufserfahrung • Mind. 3 Jahre praktische Erfahrung im Bereich Compliance/Qualitätssicherung von pharmazeutischen, chemischen oder biotechnologischen Anlagen • Praktische Erfahrung in der Umsetzung von technischen GMP-Anforderungen der Zulassungsbehörden (RHI, FDA, EMA etc.) in Investitionsprojekten bzw. in der galenischen/chemischen Produktion• Gute EDV-Kenntnisse (GSuite), Erfahrung in TrackWise, Condor und Veeva von Vorteil• Sehr gute Deutsch- und Englisch- Kenntnisse in Wort und Schrift Persönliche Anforderungen: • Teamplayer mit exzellenten Kommunikationseigenschaften und Verhandlungsfähigkeiten, gepaart mit der Fähigkeit effektive und vertrauensvolle Beziehungen mit Kollegen und Mitarbeitern auf verschiedensten Ebenen aufzubauen• Eigenverantwortliche und selbständige Bearbeitung komplexer Aufgaben sowie zuverlässige Durchsetzung vereinbarter Prioritäten• offen für neue Ideen und hinterfragen konventionelle Denkmuster.
    Das Department Technische Compliance ist auf der Suche nach einem/r Compliance Experte (m/w/d) für die Betreuung & Implementierung von Qualitätssystemen innerhalb des Engineerings & Energiebetrieben/Werkstätten. Allgemeine Informationen: • Startdatum: asap• Spätestmögliches Startdatum: 01.11.2021• Enddatum: Jahresvertrag• Verlängerung: Wahrscheinlich• Workload: 80-100%• Home Office: nach Absprache zeitweise möglich  Aufgaben & Verantwortlichkeiten: • Unterstützung interner Kunden als anerkannter Berater in sämtlichen technischen GMP Fragestellungen, z.B. Umsetzung von Qualifizierungsanforderungen• Monitoring von Key Performance Indices und Fälligkeiten• Business Process Support für Risk-, Deviation-, Change- und CAPA-Management in enger Kollaboration mit den Qualitätsorganisationen am Standort• Inspektionssupport für den Bereich Technik, Kontakt zu den Subject Matter Experts• Unterstützung und aktive Mitarbeit in agilen Organisationsformen• Unterstützung im Records-Management Must Haves: • Abgeschlossenes technisches Studium oder vergleichbare Ausbildung mit langjähriger Berufserfahrung • Mind. 3 Jahre praktische Erfahrung im Bereich Compliance/Qualitätssicherung von pharmazeutischen, chemischen oder biotechnologischen Anlagen • Praktische Erfahrung in der Umsetzung von technischen GMP-Anforderungen der Zulassungsbehörden (RHI, FDA, EMA etc.) in Investitionsprojekten bzw. in der galenischen/chemischen Produktion• Gute EDV-Kenntnisse (GSuite), Erfahrung in TrackWise, Condor und Veeva von Vorteil• Sehr gute Deutsch- und Englisch- Kenntnisse in Wort und Schrift Persönliche Anforderungen: • Teamplayer mit exzellenten Kommunikationseigenschaften und Verhandlungsfähigkeiten, gepaart mit der Fähigkeit effektive und vertrauensvolle Beziehungen mit Kollegen und Mitarbeitern auf verschiedensten Ebenen aufzubauen• Eigenverantwortliche und selbständige Bearbeitung komplexer Aufgaben sowie zuverlässige Durchsetzung vereinbarter Prioritäten• offen für neue Ideen und hinterfragen konventionelle Denkmuster.
    • basel, basel-stadt
    • temporary
    For our client, a growing company in the pharmaceutical industry, we are looking for a :Planning Coordinator/Expert Location: BaselContract: Temporary for 6 months with possibility to extend or become permanentMain objective:This position is responsible to manage the operational planning incl. inbound flows (orders and shipments) and the associated tools/processes (incl. Artwork management). Acts as Super User in the management of the SAP setup (MM, IBP)Your Main Responsibilities:  Perform monthly supply planning operations in close cooperation with the Global Planning Manager (in Excel and SAP IBP)Supply PO placement with suppliers and follow upManagement of inbound flows incl. organization of inbound shipments from supplier to HUBSuper User SAP (MM,IBP) supporting the SAP implementations and ensuring correct setup of SAP in collaboration with the business and ITMaintain SAP Master Data accuracyManage/support projects in the Supply Chain areaEnsure operationally with external Artwork Supplier and internal functions management of Artwork changesYour profile:University Degree in Supply Chain or very Supply Chain related functionsMin 3 years on hand experience as Planning Coordinator/Expert with intense exposure to SAP and Artwork creation, preferably in the pharmaceutical/Consumer Health businessVery strong analytical thinkingSelf-starter, able to work independently and picking up responsibility in a newly created Supply chainContinuous Improvement mindset.Ability to work accurately under pressureAbility to work in remote teamsSAP (IBP, MM)MS Excel (very good knowledge incl. creation of own complex reports/spreadsheets)Very good English (must have),French & Italian (asset) Please note that a valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position 
    For our client, a growing company in the pharmaceutical industry, we are looking for a :Planning Coordinator/Expert Location: BaselContract: Temporary for 6 months with possibility to extend or become permanentMain objective:This position is responsible to manage the operational planning incl. inbound flows (orders and shipments) and the associated tools/processes (incl. Artwork management). Acts as Super User in the management of the SAP setup (MM, IBP)Your Main Responsibilities:  Perform monthly supply planning operations in close cooperation with the Global Planning Manager (in Excel and SAP IBP)Supply PO placement with suppliers and follow upManagement of inbound flows incl. organization of inbound shipments from supplier to HUBSuper User SAP (MM,IBP) supporting the SAP implementations and ensuring correct setup of SAP in collaboration with the business and ITMaintain SAP Master Data accuracyManage/support projects in the Supply Chain areaEnsure operationally with external Artwork Supplier and internal functions management of Artwork changesYour profile:University Degree in Supply Chain or very Supply Chain related functionsMin 3 years on hand experience as Planning Coordinator/Expert with intense exposure to SAP and Artwork creation, preferably in the pharmaceutical/Consumer Health businessVery strong analytical thinkingSelf-starter, able to work independently and picking up responsibility in a newly created Supply chainContinuous Improvement mindset.Ability to work accurately under pressureAbility to work in remote teamsSAP (IBP, MM)MS Excel (very good knowledge incl. creation of own complex reports/spreadsheets)Very good English (must have),French & Italian (asset) Please note that a valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position 

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