Patient Safety Senior Director

Encontrado en: beBee S ES - hace 2 semanas


SFEL RD SANT FELIU DE LLOBR, España Almirall A tiempo completo
Mission

The director of patient safety at Almirall is accountable for:

  • Establishing and maintain a Global/Corporate Pharmacovigilance system that protects patients and users of Almirall medical solutions.
  • Acting as the EU Qualified Person for Pharmacovigilance (QPPV) and UK QPPV.
  • Ensures an adequate safety profile of investigational medicinal products and helps protecting the safety and wellbeing of subjects and patients participating in development projects.
  • Role open in Hamburg or Barcelona, we will consider candidates from both locations. 


    
 

Education & Experience
  • Life science degree (preferably MD) with high level of pharmacovigilance expertise (minimum of 10 years)
  • Knowledge of European regulatory requirements relating to PV
  • PV systems experience, GVP audits and regulatory inspections experience.
  • Proficient command in English, fluency in Spanish desirable
  • Team management experience
Tasks and Responsibilities
  • Manages the Almirall Corporate Patient Safety Team and coordinate Safety activities for all Almirall products, both investigational and marketed products. Coordinates communication of safety issues both internally and to health authorities.
  • Directs the activities of CPS concerning the processing and optimal management of pharmacovigilance-related safety information on Almirall products towards internal stakeholders (i.e headquarters, management, market companies) and external stakeholders (business partners, regulatory authorities).
  • Ensures proper safety surveillance of Almirall marketed products. Oversee ongoing and periodic review of safety information to detect and investigate safety signals in order to establish/maintain adequate safety profile for Almirall products; Recommends regulatory actions and risk minimisation measures as required.
  • Responsible for clinical safety aspects of development projects along with clinical department since first in man studies such as: safety monitoring, B/R balance assessment, periodic safety reports (eg. DSURs) management, SAE management and Risk Management activities.
  • Maintains compliance with patient safety legal requirements and international guidelines.
  • Ensures that there is quality management system in place suitable for Pharmacovigilance.
  • Is the European Union Qualified person responsible for Pharmacovigilance (EUQPPV) and UK QPPV.

  • ADME & DMPK Senior Scientist

    Encontrado en: beBee jobs ES - hace 6 días


    SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completo

    MissionBe a member of R&D project teams to provide expert ADME&DMPK support across a project lifecycle in a multidisciplinary environment with special focus between the early stages of drug discovery through candidate nomination and early clinical development. Ensure that ADME profiling, PK/PD, M&S, human dose predictions or other related deliverables are...

  • ADME & DMPK Senior Scientist

    Encontrado en: beBee S ES - hace 4 días


    SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completo

    Mission Be a member of R&D project teams to provide expert ADME&DMPK support across a project lifecycle in a multidisciplinary environment with special focus between the early stages of drug discovery through candidate nomination and early clinical development.  Ensure that ADME profiling, PK/PD, M&S, human dose predictions or other related deliverables...

  • ADME & DMPK Senior Scientist

    Encontrado en: beBee jobs ES - hace 4 días


    SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completo

    MissionBe a member of R&D project teams to provide expert ADME&DMPK support across a project lifecycle in a multidisciplinary environment with special focus between the early stages of drug discovery through candidate nomination and early clinical development. Ensure that ADME profiling, PK/PD, M&S, human dose predictions or other related deliverables are...

  • ADME & DMPK Senior Scientist

    Encontrado en: beBee S ES - hace 7 días


    SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completo

    Mission Be a member of R&D project teams to provide expert ADME&DMPK support across a project lifecycle in a multidisciplinary environment with special focus between the early stages of drug discovery through candidate nomination and early clinical development.  Ensure that ADME profiling, PK/PD, M&S, human dose predictions or other related deliverables...

  • Senior Scientist

    Encontrado en: beBee jobs ES - hace 6 días


    SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completo

    MissionAlmirall is a global pharmaceutical company with a focus on Medical Dermatology. Our goal is to develop novel therapeutics to tackle unmet medical need in the fields of immune inflammatory skin diseases, rare skin diseases and non-melanoma skin cancers.We are seeking a talented cellular immunologist to join our Molecular and Cell Biology (MCB) team...

  • Senior Scientist

    Encontrado en: beBee S ES - hace 7 días


    SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completo

    Mission Almirall is a global pharmaceutical company with a focus on Medical Dermatology. Our goal is to develop novel therapeutics to tackle unmet medical need in the fields of immune inflammatory skin diseases, rare skin diseases and non-melanoma skin cancers. We are seeking a talented cellular immunologist to join our Molecular and Cell Biology (MCB) team...

  • Clinical Development Physician

    Encontrado en: beBee S ES - hace 3 semanas


    SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completo

    Mission Clinical Development Physician is an important part of Global Study Teams within Global Clinical Development. Provides medical input and support to the study team for a given clinical development project in line within defined clinical development strategy, Target Product Profile (TPP) and target labelling, in collaboration with the cross functional...

  • Clinical Development Physician

    Encontrado en: beBee S ES - hace 2 semanas


    SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completo

    Mission Clinical Development Physician is an important part of Global Study Teams within Global Clinical Development. Provides medical input and support to the study team for a given clinical development project in line within defined clinical development strategy, Target Product Profile (TPP) and target labelling, in collaboration with the cross functional...

  • Director Medical Device Safety

    Encontrado en: beBee S ES - hace 4 semanas


    Sant Pau d'Ordal, España Bayer AG A tiempo completo

    Director Medical Device Safety Description Purpose: The Director of Medical Device Safety (MDS) leads and develops global Pharmacovigilance (PV) business processes and analyses clinical data sets related to complaint handling, regulatory reporting and clinical development for Bayer medical devices and combination products. The Director of MDS is an...


  • Sant Feliu de Llobregat, España Almirall A tiempo completo

    Fecha: 25 abr. 2024- Ubicación: SFEL - R&D SANT FELIU DE LLOBR**Mission**: **Tasks and Responsabilities**: - Responsible for outsourcing and coordination of experimental ADME/DMPK in vitro or in vivo studies when needed. - Responsible for all bioanalytical needs, in house or from external vendors, to support ADME/DMPK studies. - PK/PD support and use of...

  • Senior Bioprocess Scientist

    Encontrado en: Talent ES C2 - hace 2 semanas


    Sant Feliu de Llobregat, España Centrient Pharmaceuticals Netherlands A tiempo completo

    Centrient Pharmaceuticals is the leading manufacturer of beta-lactam antibiotics, and a provider of next generation statins and anti-fungals. We produce and sell intermediates, active pharmaceutical ingredients and finished dosage forms.We stand proudly at the centre of modern healthcare, as a maker of essential and life-saving medicines. With our commitment...

  • Senior Bioprocess Scientist

    Encontrado en: Talent ES C2 - hace 3 días


    Sant Feliu de Llobregat, España Centrient Pharmaceuticals Netherlands A tiempo completo

    Centrient Pharmaceuticals is the leading manufacturer of beta-lactam antibiotics, and a provider of next generation statins and anti-fungals. We produce and sell intermediates, active pharmaceutical ingredients and finished dosage forms.We stand proudly at the centre of modern healthcare, as a maker of essential and life-saving medicines. With our commitment...

  • Risk, Health

    hace 2 semanas


    San Fernando de Henares, España Rentokil Initial A tiempo completo

    Descripción de la empresa Descripción del empleo ¿Te gustaría formar parte de Rentokil Initial, la empresa líder mundial en servicios de Control de Plagas e Higiene Ambiental? Nuestra vocación de servicio e innovación nos ha llevado a convertirnos en una de las mayores compañías internacionales de servicios para empresas y particulares del mundo....


  • San Fernando de Henares, España Cummins Inc. A tiempo completo

    **Europe Powergen Projects Senior HSE Engineer** **Description** Opportunity to be ourPowergen Projects **"** **Senior HSE Engineer"** at Cummins Europe, based in Madrid. Work model: hybrid. 40% travel availability. Very high level of English required. Relocation is not eligible. **In this role, you will make an impact in some of the following ways**: -...

  • Director of Product

    hace 7 días


    Palma de Mallorca, España Ambitions Recruitment A tiempo completo

    **DIRECTOR OF PRODUCT (TECHNICAL)** **ROMANIA OR PALMA** **GREAT BASIC, BONUS AND BENEFITS** **Who you’ll be working for**: My customer is looking for an experienced Director of Product (technical), to join their hugely successful and very well-established, international travel business. With operations in over 120 countries and a significant head count...

  • Senior Scientist

    hace 6 días


    Sant Feliu de Llobregat, España Almirall A tiempo completo

    **Date**:25 Apr 2024 **Location**: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - Spain **Company**:Almirall **Mission**: Almirall is a global pharmaceutical company with a focus on Medical Dermatology. Our goal is to develop novel therapeutics to tackle unmet medical need in the fields of immune inflammatory skin diseases, rare skin diseases and non-melanoma...


  • San Fernando de Henares, España Cummins A tiempo completo

    Opportunity to be ourPowergen Projects **"** **Senior HSE Engineer"** at Cummins Europe, based in Madrid. Work model: hybrid. 40% travel availability. Very high level of English required. Relocation is not eligible. **In this role, you will make an impact in some of the following ways**: - Actively promotes health, safety and environmental awareness and...

  • Europe Powergen Projects Senior HSE Engineer

    Encontrado en: beBee S ES - hace 6 días


    Poligono de San Fernando de Henares, España Cummins A tiempo completo

    Opportunity to be our Powergen Projects "Senior HSE Engineer" at Cummins Europe, based in Madrid. Work model: hybrid. 40% travel availability. Very high level of English required. Relocation is not eligible. In this role, you will make an impact in some of the following ways: Actively promotes health, safety and environmental awareness and...

  • Europe Powergen Projects Senior HSE Engineer

    Encontrado en: beBee jobs ES - hace 5 días


    Poligono de San Fernando de Henares, España Cummins A tiempo completo

    Opportunity to be our Powergen Projects "Senior HSE Engineer" at Cummins Europe, based in Madrid.Work model: hybrid. 40% travel availability. Very high level of English required. Relocation is not eligible.In this role, you will make an impact in some of the following ways:Actively promotes health, safety and environmental awareness and applies technical...


  • San Fernando de Henares, España Cummins Inc. A tiempo completo

    DescriptionOpportunity to be ourPowergen Projects " Senior HSE Engineer" at Cummins Europe, based in Madrid. Work model: hybrid. 40% travel availability. Very high level of English required. Relocation is not eligible. In this role, you will make an impact in some of the following ways: Actively promotes health, safety and environmental awareness and applies...