Description : ENCADREMENT   * ENCADRER ET ACCOMPAGNER son équipe afin que les collaborateurs concernés : responsables produits, attaché de vigilance, administrateur de base de données puissent répondre à leurs missions, * PLANIFICATION ET ORGANISATION : Superviser et organiser le planning de travail, répartir les tâches par ses collaborateurs et s'assurer que les livrables soient fournis dans les délais impartis, * RÉSOLUTION DE PROBLÈMES : Savoir gérer les priorités et les situations imprévues, en prenant des décisions rapides et efficaces pour résoudre les problèmes rencontrés, * COMMUNICATION : Maintenir une communication claire et efficace au sein de l'équipe, avec sa hiérarchie, l’EUQPPV et les autres départements, alerter en cas d’alerte ou de conflits de priorités qui ne soient pas dans son périmètre, * FORMATION ET DÉVELOPPEMENT : Organiser des sessions de formation continue et accompagner le développement professionnel des membres de l'équipe, identifier les besoins en formation le cas échéant, * SUIVI ET ÉVALUATION : Définir les objectifs en collaboration avec les membres de son équipe selon les recommandations du groupe et de sa hiérarchie, évaluer régulièrement les performances de son équipe, fournir des retours constructifs à sa hiérarchie. * SUIVI DU PROFIL DE SÉCURITÉ DES PRODUITS DE SANTÉ POUR S’ASSURER DE LEUR BON USAGE ET DE LA SÉCURITÉ DU PATIENT * SUIVRE les effets indésirables des produits commercialisés et s’assurer de la mise à jour des documents de référence réglementaire (RSI), * SUIVRE l’évaluation du rapport bénéfice/risque du produit de santé en développement et/ou commercialisés, * DÉVELOPPER les plans de gestion des risques pour promouvoir le bon usage des produits de santé et déploiement au niveau des filiales, * COMMUNIQUER régulièrement à sa hiérarchie et à l’EUQPPV les informations relatives à la sécurité des produits, * ASSURER un rôle d’expert-conseil en interne auprès de sa hiérarchie et du EUQPPV pour toutes les questions de vigilance relatives à son périmètre, * CONSEILLER ET PRÉPARER les argumentaires en cas de questions des autorités, de crise ou d’action juridique relatives aux données de vigilance, * CONTRÔLER l’application de la réglementation en matière de vigilance dans son équipe. SUPERVISION DE LA GESTION DES CAS DE VIGILANCE * GESTION DES RAPPORTS INDIVIDUELS D'ÉVÉNEMENTS INDÉSIRABLES : supervise la bonne gestion des cas de vigilance (incluant les contrôles de qualité) : réception, enregistrement, traitement et déclaration des rapports d'événements indésirables qu’ils soient traités en interne ou sous-traités pour les produits suivis par le service, * ADMINISTRATION DE LA BASE DE DONNÉES DES VIGILANCES : supervise la bonne gestion et maintenance de la base de données des vigilances via l’administrateur dédié, afin de maintenir la base en état validé (gestion des mantis, release notes et autres mises à jour, intégration des nouveaux produits et études…) et de pouvoir gérer les incidents au quotidien, * EXTRACTION DES DONNÉES DE VIGILANCE : supervise la bonne exécution des extractions de la base de données (exhaustivité et exactitude des données attendues, dans les délais impartis), * RÉCONCILIATIONS ET COMPLIANCE : supervise les réconciliations effectuées en relation avec la base de données des vigilances, supervise la bonne exécution et les résultats des indicateurs qualité qui s’y réfèrent.     ACTIVITÉS TRANSVERSES * Suivi et renforcement si nécessaire, des indicateurs de performance relatifs à son périmètre de responsabilités, * Participation à la veille scientifique et réglementaire internationale avec un intérêt particulier pour les sujets relatifs au portefeuille de produits du service et aux bases de données de vigilance, * Organisation de la maintenance de la documentation qualité de son périmètre, * Organisation de la préparation et du déroulement des audits et inspections relatifs aux activités de son équipe, et des actions correctives et préventives qui en découleraient, * Organisation des supports de formation liés à son domaine d’activité, s’assure de la formation adéquate de son équipe, * Optimisation des activités de son périmètre en collaboration avec sa hiérarchie et l’EUQPPV.   Profil recherché : De formation scientifique avec une spécialisation en pharmacovigilance, vous avez occupé un poste en vigilance pendant au moins 7 années incluant des fonctions managériales,  • Avoir rédigé des rapports de sécurité : PBRER, RMP, ACO,  • Avoir participé à la gestion des signaux relatifs aux médicaments, • Connaître les principes de fonctionnement d’une base de données de vigilance, le circuit des cas de vigilance, ainsi que les systèmes de requêtage SAVOIR-FAIRE • Connaissance réglementaire : Maîtrise des réglementations nationales et internationales en matière de vigilance (pharmaco, matério et nutrivigilance) et capacité à les appliquer dans les pratiques quotidiennes, • Analyse des données : Comp...

Localisation : Saint-Clément-de-Rivière (34) - Télétravail 2 à 3 jours/semaine Type de contrat : CDI - Temps plein (35h) Expérience : 2 à 3 ans minimum en pharmacovigilance Rémunération : 35 à 42K€, selon profil + avantages ________________________________________ À propos de PHARMYA: Fondée en 2013, PHARMYA est une société française en pleine croissance, reconnue pour son expertise dans la prestation de services en pharmacovigilance. Nous accompagnons les industries pharmaceutiques, biotechnologiques ainsi que les centres de recherche dans la gestion de la sécurité des médicaments, à travers une large gamme de services personnalisés. Nous plaçons l'humain, l'expertise et la qualité au cœur de nos engagements. Rejoindre PHARMYA, c'est intégrer une entreprise à taille humaine, dynamique et attentive au bien-être de ses collaborateurs. ________________________________________ Le poste: Dans le cadre de notre développement, nous recherchons un(e) Pharmacien(ne) Pharmacovigilance pour renforcer notre équipe. Le poste est hybride : 2 jours de présence sur site à Saint-Clément-de-Rivière sont attendus après la phase d'intégration, le reste pouvant être effectué en télétravail. Date de prise de poste: septembre 2025, flexible en fonction de vos disponibilités. ________________________________________ Vos missions: En tant que Pharmacien Pharmacovigilance, vous serez amené(e) à gérer les activités de pharmacovigilance suivantes : - Mise en place et gestion de systèmes de pharmacovigilance - Réception, traitement, évaluation et suivi des cas de pharmacovigilance - Veille bibliographique - Participation aux audits, inspections et réunions clients - Rédaction de documents de sécurité (rapports périodiques, PSUR, DSUR, etc.) - Détection de signaux (signal detection) - Rédaction et mise à jour des PSMF et procédures qualité - Implication dans la démarche Qualité de l'entreprise - Possibilité d'occuper des rôles de RPV / QPPV local(e) / deputy selon les projets ________________________________________ Votre profil: - Pharmacien(ne) ou médecin diplômé(e) exigé - Expérience de 2 à 3 ans minimum en pharmacovigilance dans un environnement similaire (CRO, labo, biotech.) - Bonne maîtrise des outils informatiques et des bases de données de pharmacovigilance - Maîtrise de l'anglais professionnel, à l'écrit comme à l'oral - Autonomie, rigueur, sens du service client et esprit d'équipe sont essentiels ________________________________________ Ce que nous offrons: - CDI - Temps plein (35h) - Salaire : 35 à 42 K€ selon expérience - Prime annuelle équivalente à un 13e mois - Horaires flexibles (9h-17h en moyenne, adaptables selon contraintes personnelles) - Télétravail jusqu'à 3 jours/semaine après intégration - Mutuelle prise en charge à 100 % par l'employeur - Parcours de formation complet et individualisé - Environnement de travail bienveillant et collaboratif ________________________________________ Intéressé(e) ? Envoyez-nous votre CV et lettre de motivation à : Nous serons ravis d'étudier votre candidature en toute confidentialité.

Buscamos un/a consultor/a SAP con experiencia en el sector farmacéutico. Responsabilidades: -Mantenimiento y evolución del sistema SAP (actual SAP R3, en proceso de migración a S4/HANA). -Monitorización y resolución de incidencias. -Trabajar en proyectos y servicios con consultores funcionales externos, analistas de negocio y usuarios finales para entender los requerimientos técnicos y funcionales y proveer soluciones que cubran dichos requerimientos. -Supervisión del cumplimiento de regulaciones GMP en el ámbito SAP (infraestructura y aplicaciones). -Aseguramiento de seguridad de los datos de los sistemas. Se requiere: -Profundo conocimiento del ERP SAP, especialmente en los módulos relacionados con la producción de una empresa Farmacéutica (Controlling industrial, compras, ventas, planificación y producción, mantenimiento de planta, almacenes, calidad). -Deseables conocimientos del entorno S4/HANA. -Experiencia demostrable en proyectos de integración con sistemas de producción (MES, sistemas de serialización, sistemas de pesadas, etc.), -Sólido conocimiento de regulaciones del sector farmacéutico, especialmente de las buenas prácticas en la fabricación. -Buen nivel de inglés. -Experiencia mínima de 5 años trabajando en una posición similar para empresas farmacéuticas o trabajando para empresas consultoras en proyectos SAP para empresas del sector. -Se valorará contar con certificaciones oficiales SAP y conocimientos en IBP..

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DIVICO CONSULTORES, S.L. como empresa de selección de personal del COFB Serveis (empresa de servicios del Colegio de Farmacéuticos de Barcelona) selecciona a Farmacéutico/as para trabajar en diferentes farmacias de Barcelona y Provincia. Ofrecemos contratos estables e indefinidos con incorporación inmediata en función de las necesidades del candidato y de la Farmacia. Jornada Laboral: 40 horas semanales en distintas jornadas laborales (mañana, tarde, o partida) Ubicación: Barcelona y Provincia. Requisitos:  Graduado en Farmacia o estudiante de último curso.  Se valora experiencia profesional.  Valorable inglés. Requisitos:Experiencia 6 meses. Valorable experiència en oficina de farmàcia , LICENCIATURA O INGENIERÍA , Llicenciatura / Grau Unviersitari en Farmàcia Condiciones laborales:Contrato laboral indefinido , Jornada completa.

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El/la Auxiliar de Farmacia presta apoyo al farmacéutico/a en las labores de dispensación, atención al cliente y gestión de los productos farmacéuticos y parafarmacéuticos. Su función principal es colaborar en la organización del establecimiento, garantizando una atención profesional, cercana y orientada a las necesidades de los pacientes. Atender al público en la dispensación de productos farmacéuticos y de parafarmacia bajo la supervisión del farmacéutico/a. Informar y orientar a los clientes sobre el uso correcto de los productos dispensados. Recepcionar, revisar y colocar los pedidos de medicamentos y productos en el almacén y en el punto de venta. Controlar caducidades, conservación y stock de los productos. Colaborar en la preparación de pedidos a domicilio, fórmulas magistrales y otros servicios complementarios de la farmacia. Mantener en orden y limpieza la zona de trabajo, garantizando la correcta imagen del establecimiento. Apoyar en la gestión administrativa básica: facturación, archivo y control de recetas..

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(Senior-) Director, Clinical Development Mainz, Germany; Cambridge, US; Gaithersburg, US; London, United Kingdom; Munich, Germany | full time | Job ID:9676 The (Senior-) Director Clinical Development will collaborate closely with the VP of Clinical Development to lead clinical strategies for assigned programs. This role involves overseeing the design and execution of clinical trials from early to late stages, ensuring data integrity, patient safety, and regulatory approval. You will lead a matrix team and apply your deep understanding of scientific, medical, and disease biology to guide decisions. Oversee and steer clinical trial design and execution, developing clinical plans for new compounds and leading towards regulatory approval. Collaborate with the VP to operationalize clinical strategies for assigned portfolios. Lead program strategy, development plans, and submission processes. Serve as Program Lead, guiding core teams and aligning objectives across functions. Ensure medical and safety aspects of studies, including risk-benefit assessments and medical queries. Work closely with Clinical Operations to ensure patient-centric drug development. Drive innovation in trial design, leveraging digital endpoints and real-world evidence. Prepare key clinical documents (e.g., Investigator’s Brochures, NDAs) and ensure high-quality medical content in Clinical Study Reports. Manage relationships with external stakeholders and represent the team in governance meetings. M.D. with strong scientific and clinical background in Immuno-Oncology, Oncology Several years of experience within Immuno-Oncology, Oncology at the biotech/pharmaceutical and the academic setting, including leading clinical development programs from exploratory Phase I/II clinical studies through late stage development in Phase III and NDA submission. Thorough understanding of the clinical and scientific methods and approaches used in clinical development studies, as novel clinical study designs, application of companion diagnostics for patient selection, clinical pharmacology/ translational modeling and biostatistics. Complemented with several years of experience on confirmatory PH3 trial design and respective dossier preparation and submission activities. Experienced in global health authority interactions (EMA, FDA, MHRA, CDE). Having participated or led a drug development program to successful registration is an advantage. Strong medical experience in overseeing and interpreting safety and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects. Ability to apply situational management style to both mentor and accelerate capabilities of its reports It's our priority to support you: Your flexibility: flexible hours | vacation account Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential Your health and lifestyle: Company bike Your mobility: Job ticket | Deutschlandticket Your life phases: Employer-funded pension | Childcare

Düsseldorf University Hospital (UKD) is the largest hospital in the state capital and one of the most important medical centers in North Rhine-Westphalia. The 9,300 employees at UKD and its subsidiaries are committed to treating over 45,000 inpatients and 270,000 outpatients every year. The UKD stands for international excellence in patient care, research and teaching, as well as for innovative and safe diagnostics, therapy and prevention. Patients benefit from the intensive interdisciplinary cooperation between the 60 clinics and institutes. The particular strength of the University Hospital is the close integration of clinical and research work for the safe application of new methods. Tomorrow's medicine is being created at the UKD. Every day. The Institute of Molecular Medicine II is looking for two Postdoctoral Research Associates in tumor immunology (m/w/d) Start date as soon as possible. The position is subject to the German Academic Fixed-Term Contract Act (WissZeitVG, Section 2 (2)) and is initially limited to two years until the end of the project. The Institute of Molecular Medicine II, headed by Prof. Dr. Philipp Lang, focuses on the molecular basis of infections and immune responses and the development of new therapeutic options in connection with antitumor immune responses. This involves immune mechanisms during chronic viral infections and tumor growth, including innate and adaptive immunity. A central focus lies in understanding immune dysfunctions associated with these diseases. Our goal is to elucidate how chronic viral infections develop and to identify mechanisms that drive tumor growth, thereby contributing to the development of novel therapeutic strategies within a basic research framework. The Institute of Molecular Medicine II is actively involved in several research networks dedicated to these topics and applies a translational approach across its individual research projects. The current research project will focus on improving immunotherapy regimens. Specifically, several immunotherapy model systems will be applied in preclinical murine models (e.g.: CAR-T, Virotherapy, BiTEs). We aim to use small DNA molecules to cleave target sequences and thereby improve anti-tumor immunity. Experience in immunology, tumor biology, molecular biology, and delivery/lipid nanoparticles combined with enthusiasm about experimental science in an international team is desired. Coordination, organization, and scientific implementation of the research project Development of new scientific research areas and publication of research results in the form of articles in journals Administration of project- and laboratory-related applications, as well as laboratory animal management University degree in medicine, biology, biomedicine, or related fields Doctorate or Ph.D. related to the advertised areas of responsibility Comprehensive experience in immunological and molecular biology in vivo and in vitro techniques Profound knowledge of murine animal models Successful publication of articles in renowned scientific journals is desirable High motivation, dedication, and a passion for making a difference through basic research In addition, we are looking for Interest in translational immunological research Ability to work on complex problems in a structured and solution-oriented manner Friendly and situation-appropriate communication skills, as well as strong teamwork skills Excellent leadership qualities Very good verbal and written communication skills in English and preferably also in German We offer you the opportunity to work in a highly motivated, international team on an exciting research project with great translational potential in the field of immuno-oncology. You can expect modern laboratories and access to state-of-the-art technologies. Experience with translational projects in immune-oncology Highly motivated international team Enthusiastic research project with translational potential ...

Senior Director/Director Clinical Development New Jersey, US; Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany | full time | Job ID:9682 The (Senior) Director, Clinical Development will collaborate closely with the VP of Clinical Development to lead clinical strategies for assigned programs. This role involves overseeing the design and execution of clinical trials from early to late stages, ensuring data integrity, patient safety, and regulatory approval. You will lead a matrix team and apply your deep understanding of scientific, medical, and disease biology to guide decisions. Oversee and steer clinical trial design and execution, developing clinical plans for new compounds and leading towards regulatory approval. Collaborate with the VP to operationalize clinical strategies for assigned portfolios. Lead program strategy, development plans, and submission processes. Serve as Program Lead, guiding core teams and aligning objectives across functions. Ensure medical and safety aspects of studies, including risk-benefit assessments and medical queries. Work closely with Clinical Operations to ensure patient-centric drug development. Drive innovation in trial design, leveraging digital endpoints and real-world evidence. Prepare key clinical documents (e.g., Investigator’s Brochures, NDAs) and ensure high-quality medical content in Clinical Study Reports. Manage relationships with external stakeholders and represent the team in governance meetings. M.D. with strong scientific and clinical background in Immuno-Oncology, Oncology Several years of experience within Immuno-Oncology, Oncology at the biotech/pharmaceutical and the academic setting, including leading clinical development programs from exploratory Phase I/II clinical studies through late stage development in Phase III and NDA submission. Thorough understanding of the clinical and scientific methods and approaches used in clinical development studies, as novel clinical study designs, application of companion diagnostics for patient selection, clinical pharmacology/ translational modeling and biostatistics. Complemented with several years of experience on confirmatory PH3 trial design and respective dossier preparation and submission activities. Experienced in global health authority interactions (EMA, FDA, MHRA, CDE). Having participated or led a drug development program to successful registration is an advantage. Strong medical experience in overseeing and interpreting safety and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects. Ability to apply situational management style to both mentor and accelerate capabilities of its reports Expected Pay Range: $267,000/year to $397000/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities. BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to: Medical, Dental and Vision Insurance Life, AD&D, Critical Illness Insurance Pre-tax HSA & FSA, DCRA Spending Accounts Employee Assistance & Concierge Program (EAP) available 24/7 Parental and Childbirth Leave & Family Planning Assistance Sitterstream: Virtual Tutoring & Childcare Membership Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown. 401(K) Plan with Company Match Tuition Reimbursement & Student Loan Assistance Programs Wellbeing Incentive Platforms & Incentives Professional Development Programs Commuting Allowance and subsidized parking Discounted Home, Au...

Executive Director Medical Oncology Germany Munich, Germany | full time | Job ID:9905 As the Executive Director Medical Oncology for Germany, you will be responsible for leading the medical strategy and activities related to oncology within the country. Reporting directly to the General Manager, you will act as the key medical expert, ensuring scientific excellence, compliance, and alignment with the company’s global and regional strategies while addressing local needs. In this role you will also interact closely with the regional Medical Head Oncology and global therapeutic leads. This role requires a strong combination of leadership, strategic thinking, and scientific expertise to drive impactful outcomes for patients, healthcare providers, and the organization. Develop and execute the medical strategy for oncology in Germany, ensuring alignment with global and regional priorities while addressing local market needs Provide strategic medical input to the General Manager and cross-functional teams, ensuring scientific integrity and patient-centricity Represent the medical function in senior leadership discussions and contribute to the overall business strategy for Germany Serve as the primary medical expert in oncology, providing scientific and clinical insights to internal and external stakeholders Build and maintain strong relationships with key opinion leaders (KOLs), healthcare professionals (HCPs), patient advocacy groups, and other external stakeholders in Germany Collaborate with clinical development and operations teams to support and accelerate global clinical trials executed in Germany Ensure compliance with ethical and regulatory standards in all research activities and medical governance Build and develop the medical team in Germany, fostering a culture of collaboration, innovation, and excellence Medical degree (MD) or equivalent is required; an advanced degree in oncology, clinical research, or related field is preferred (e.g., PhD, MBA) Minimum of 10 years of experience in medical affairs, clinical development, or related roles within the pharmaceutical or biotechnology industry, with at least 5 years focused on solid tumors Proven track record of leadership in oncology, including strategic planning and execution Experience in engaging with KOLs, HCPs, medical societies, and regulatory authorities in Germany Expertise in the field of lung and breast cancer, with experience in product launches preferred Familiarity with the German healthcare system, regulatory environment, and market access landscape Strong leadership and people management skills, with the ability to inspire and motivate teams in a fast-paced environment Excellent communication and presentation skills, both written and verbal, in German and English, with a high level of integrity and professionalism It's our priority to support you: Your flexibility: flexible hours | vacation account Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential Your health and lifestyle: Company bike Your mobility: Job ticket | Deutschlandticket Your life phases: Employer-funded pension | Childcare

Medical Director Clinical Development (Infectious Diseases) Mainz, Germany; London, United Kingdom; Munich, Germany | full time | Job ID:10513 Are you passionate about advancing medicine to unlock the full potential of the immune system against infectious diseases? Join BioNTech as a Medical Director in Clinical Development and play a key role in defining and executing the global development strategy for cutting-edge programs. Reporting to the VP of Clinical Development for Infectious Diseases, you will lead a cross-functional team to drive innovation in the design and execution of clinical trials that impact patient lives and shape BioNTech’s rapidly expanding pipeline. This exciting role offers the unique opportunity to contribute to our mission while thriving in a dynamic and fast-paced environment. Your contribution In this role, you will: Define the strategy and oversee the global execution of assigned Infectious Diseases programs, ensuring timely delivery Steer cross-functional teams, including Regulatory, Pharmacovigilance, and Biostatistics, providing clinical guidance for innovative solutions Guide the development and operationalization of Target Product Profiles, shaping clinical and submission plans Take ownership of clinical trials, leading protocol development, medical monitoring, and analysis for groundbreaking therapies Innovate trial design and accelerate program development to improve patient outcomes using advanced methodologies such as digital endpoints and PRO/HEOR tools Ensure comprehensive medical oversight, collaborating with Medical Safety and Pharmacovigilance teams to assess risks and establish Risk Management Plans Represent BioNTech to external stakeholders, including health authorities, investigators, and industry partners You are a strong fit for this role if you have: An MD or MD-PhD with a robust clinical background in infectious diseases (board certification a plus) Multiple years of experience in early- to late-stage vaccine or therapeutic development within the industry Expertise in clinical trial strategy, design, and execution, including Phase I/II/III studies and regulatory submissions In-depth knowledge of FDA, EMA, ICH, and GCP guidelines, with prior interaction with regulatory agencies preferred Strong leadership capabilities, including experience managing cross-functional matrices and delivering results within deadlines Excellent interpersonal, written, and oral communication skills in English It's our priority to support you: Your flexibility: flexible hours | vacation account Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential Your health and lifestyle: Company bike Your mobility: Job ticket | Deutschlandticket Your life phases: Employer-funded pension | Childcare