Patient Safety Physician

hace 2 semanas


Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completo

Date:
Mar 13, 2023- City: SFEL - R&D SANT FELIU DE LLOBR
Mission:

Reporting into the Director of Corporate Patient Safety is responsible to support in maintaining a Global Pharmacovigilance system that protects patients and users of Almirall medical solutions performing pharmacovigilance activities to ensure the safety of the assigned Almirall products whilst meeting regulatory requirements worldwide.


Tasks and Responsibilities:

Clinical safety:

  • Participates and leads safety related operational activities of clinical trials such as SAE management, reconciliation and unblinding activities when appropriate for individual trials as well as leads DSUR preparation activities.
  • Supports and actively contributes to the safety monitoring of investigational medicinal products and participates in regulatory filings and dossiers.

Safety for marketed products:

  • Operational support to all postmarketing studies safety related activities including but not limited to ICSR management, reconciliation as well as management of safety monitoring activities.
  • Responsible for management of Aggregate Reports (eg.
PSUR, ACO) and RMPs required by regulators

  • Supports in other safety activities such as literature reviews, signal detection activities and maintenance of reference safety information for assigned products.
  • Responsible for the preparation and negotiation of PV agreements
  • Provides safety input in regulatory activities for marketed products such as renewals and rollout.
  • Contributes to the establishment and performance of the Pharmacovigilance Quality Management System, including PSMF maintenance, fulfilling KPIs and GDPR requirements, and implements the procedures required by internal policies and applicable legislation.
  • Cooperate in the conduction of internal and external audits and inspections.

Education:

  • Life science degree

Specific Knowledge:

- +5 years of experience pharmacovigilance

  • Experience in safety activities during clinical development
  • English and Spanish fluency required.
  • IT knowledge

Values & Competencies:

Competencies:

  • Personal accountability
  • Ability to work in a crossfunctional environment

Values:

  • Care; we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.
  • Courage; we challenge the status quo, we take full ownership and we learn from our success & failures
  • Innovation; we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets.
  • Simplicity; we act decisively and avoid overanalysis, we understand why before we act and we are agile & keep things simple.

  • Safety Physician Trainee

    hace 2 semanas


    Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completo

    Fecha: 27 jul Ubicación: SFEL - R&D SANT FELIU DE LLOBRMisión:Patient safety first, ensure Almirall medical solutions have an adequate benefit/risk profile ensuring benefits outweigth risksFunciones y responsabilidades:Support the patient safety team providing clinically meaningful input in pharmacovigilance activities which include but is not limited to...

  • Patient Safety Director

    hace 2 semanas


    Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completo

    Date:23 Nov 2023Location: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - SpainCompany:AlmirallMission: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...


  • Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completo

    Date:18 Jun 2024Location: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - SpainCompany:AlmirallMission:To provide medical scientific input in the corporate pharmacovigilance activities.To monitor the benefit/risk assessment of the assigned products.To work in collaboration with members of Corporate Patient Safety and other departments within Almirall.Tasks and...

  • Patient Safety

    hace 2 semanas


    Sant Cugat, Barcelona, España Ambit A tiempo completo

    Are you interested in joining a diverse and international team as a Patient Safety & Pharmacovigilance Technician at a leading pharmaceutical company? RESPONSIBILITIES : Managing case forms from clinical studies: Reporting data to the Global Safety Database and addressing queries with study leaders. Serving as a point of contact for local clinical...


  • Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completo

    Date:30 Apr 2024Location: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - SpainCompany:AlmirallMission:We are seeking a dedicated and enthusiastic trainee to support our Pharma Plant Services Operative team in the field of biological products. This is an exciting opportunity to gain hands-on experience and develop your skills in a dynamic and fast-paced...


  • Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completo

    Fecha: 01-mar-2023- Ubicación: SFEL - R&D SANT FELIU DE LLOBRMission:Leads the Early Clinical Development Group within Global Clinical Development, providing a strong link between Disease Biology and Late Phase Development.Functions and responsibilities:Reporting to the Executive Director of Global Clinical Development, the Head of Translational Medicine is...

  • Senior Clinical Scientist

    hace 2 semanas


    Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completo

    Fecha: 17 jun Ubicación: SFEL - R&D SANT FELIU DE LLOBRMission:The Senior Clinical Development Scientist is an important member of the Global Project Team, Strategic Clinical Team and Clinical Study Teams working cross functionally with other R&D and non-R&D departments such as Regulatory and Patient Safety, Disease Biology, Global Market Access and...


  • Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completo

    Fecha: 25 abr Ubicación: SFEL - R&D SANT FELIU DE LLOBRMission: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 modeling & simulation...


  • Sant Cugat, Barcelona, España Roche A tiempo completo

    The Positionfor English version see below -Als Product Safety Specialist (m / w / d) bist Du Mitglied unserer globalen Einheit Diagnostics Product Sustainability & Compliance .Die Abteilung Compliance Operations ist verantwortlich für die Daten- und Prozesse innerhalb von Diagnostics Quality & Regulatory, die eine chemikalien- und umweltrechtlich konforme...

  • Statistical Programmer 1

    hace 2 semanas


    Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completo

    Date:9 Nov 2023Location: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - SpainCompany:AlmirallMission:Overview and analyze the required statistics for clinical studies carried out by Almirall S.A.Tasks and Responsibilities:Participation in clinical trials and clinical development projects Revise study protocols. Revise Study critical documentation: Case Report Form...

  • Research Nurse

    hace 2 semanas


    Hospitalet de Llobregat, Barcelona, España IDIBELL A tiempo completo

    Reference: 23-091_SS_JNIDIBELL is looking for a Research Nurse for the Dermatology and Psoriasis Research Group**About the research groupDermatology. Psoriasis and inflammatory skin diseases research group.About the roleDevelop specialized nursing tasks in the comprehensive assessment of patients with moderate-severe psoriasis in systemic treatment.Psoriasis...


  • Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completo

    We are hiringCorporate PV Senior ScientistNeuraxpharm is searching for individuals who are passionate about making a positive impact and enhancing the lives of patients in the CNS field. We are seeking dedicated professionals who are willing to go above and beyond to achieve remarkable outcomes.By joining our team, you won't just be an employee - you'll be...


  • Sant Cugat, Barcelona, España Boehringer Ingelheim España, S.A. A tiempo completo

    The Head of Quality Medicine defines, shapes and leads the Medicine Quality Management System (QMS) in the country consistently, based on and in accordance with the global Boehringer Ingelheim Medicine QMS throughout drug development to maximize patient safety, data integrity, fast and efficient market authorizations and maintenance of our licenses.Tasks and...


  • Sant Feliu de Llobregat, España Almirall A tiempo completo

    Date: Mar 13, 2023- City: SFEL - R&D SANT FELIU DE LLOBR**Mission**: Reporting into the Director of Corporate Patient Safety is responsible to support in maintaining a Global Pharmacovigilance system that protects patients and users of Almirall medical solutions performing pharmacovigilance activities to ensure the safety of the assigned Almirall products...


  • Sant Feliu de Llobregat, España Almirall A tiempo completo

    **Date**:18 Jun 2024 **Location**: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - Spain **Company**:Almirall **Mission**: To provide medical scientific input in the corporate pharmacovigilance activities. To monitor the benefit/risk assessment of the assigned products. To work in collaboration with members of Corporate Patient Safety and other departments...

  • Patient Safety Director

    hace 4 semanas


    Sant Feliu de Llobregat, España Almirall A tiempo completo

    **Date**:23 Nov 2023 **Location**: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - Spain **Company**:Almirall **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...


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

    Mission To provide medical scientific input in the corporate pharmacovigilance  activities.  To monitor the benefit/risk assessment of the assigned products.  To work in collaboration with members of Corporate Patient Safety and other  departments within Almirall. Tasks and Responsibilities - Is responsible for the overview/medical assessment of...


  • Sant Feliu de Llobregat, España Almirall A tiempo completo

    Date: May 15, 2024- City: SFEL - R&D SANT FELIU DE LLOBR**Mission**: Almirall is a global pharmaceutical company with 1,765 employees with direct presence in more than 20 countries. Almirall has consolidated international coverage on a global scale thanks to owned subsidiaries and sales agreements with the most prestigious partners in key markets such as the...


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

    MissionTo provide medical scientific input in the corporate pharmacovigilance activities. To monitor the benefit/risk assessment of the assigned products. To work in collaboration with members of Corporate Patient Safety and other departments within Almirall.Tasks and ResponsibilitiesIs responsible for the overview/medical assessment of Individual case...


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

    MissionWe are seeking a dedicated and enthusiastic Trainee Physician to contribute to our clinical development projects. This role offers an exciting opportunity to gain hands-on experience in a pharmaceutical company focused on developing innovative medicines for patients with underserved medical dermatology diseases. Tasks and Responsibilities In...


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

    Mission We are seeking a dedicated and enthusiastic Trainee Physician to contribute to our clinical development projects. This role offers an exciting opportunity to gain hands-on experience in a pharmaceutical company focused on developing innovative medicines for patients with underserved medical dermatology diseases.  Tasks and Responsibilities   In...


  • Sant Feliu de Llobregat, España Almirall A tiempo completo

    **Date**:30 Apr 2024 **Location**: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - Spain **Company**:Almirall **Mission**: We are seeking a dedicated and enthusiastic trainee to support our Pharma Plant Services Operative team in the field of biological products. This is an exciting opportunity to gain hands-on experience and develop your skills in a dynamic and...


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

    Mission Almirall is a global pharmaceutical company with 1,765 employees with direct presence in more than 20 countries. Almirall has consolidated international coverage on a global scale thanks to owned subsidiaries and sales agreements with the most prestigious partners in key markets such as the USA, Japan and China. We have helped to positively change...


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

    MissionAlmirall is a global pharmaceutical company with 1,765 employees with direct presence in more than 20 countries. Almirall has consolidated international coverage on a global scale thanks to owned subsidiaries and sales agreements with the most prestigious partners in key markets such as the USA, Japan and China.We have helped to positively change...


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

    MissionAlmirall is a global pharmaceutical company with 1,765 employees with direct presence in more than 20 countries. Almirall has consolidated international coverage on a global scale thanks to owned subsidiaries and sales agreements with the most prestigious partners in key markets such as the USA, Japan and China.We have helped to positively change...


  • 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...


  • Tratamiento De Aguas (Goloso, El), España GSK A tiempo completo

    **Site Name**: Italy - Siena, Belgium-Wavre, GSK House, GSK Tres Cantos, Madrid, UK - Hertfordshire - Stevenage **Posted Date**: May 12 2023 **Senior Project Physician** Are you interested in a highly visible, highly impactful role that allows you to make significant contributions to the development of vaccines against diseases of global health...


  • Tratamiento De Aguas (Goloso, El), España GSK A tiempo completo

    Site Name: Italy - Siena, Belgium-Wavre, GSK House, GSK Tres Cantos, Madrid, UK - Hertfordshire - StevenagePosted Date: May Senior Project PhysicianAre you interested in a highly visible, highly impactful role that allows you to make significant contributions to the development of vaccines against diseases of global health importance? A pivotal role in...

  • Patient Safety

    hace 1 mes


    Sant Cugat del Vallès, España Ambit A tiempo completo

    Would you like to work in a global, multicultural and multilingual team as a Patient Safety & Pharmacovigilance Technician   in a multinational pharmaceutical? TASKS : Management of case forms received in the context of clinical studies, including:Transmission of information to the Global Safety Database.Management of queries generated from the...

  • Patient Services Manager

    hace 3 semanas


    Almenara de Tormes, España HHS Culinary and Nutrition Solutions, LLC A tiempo completo

    **Patient Services Manager, Hospital Food Service** **Bench Position** **Salary 63,000.00** **Patient Services Manager**: Be an integral part of the healing process by ensuring food quality, service, safety, and sanitation are provided for all patients. Lead a goal-oriented patient ambassador team to create an environment that is effective and productive,...

  • Patient Services Manager

    hace 2 semanas


    Almenara de Tormes, Salamanca, España HHS Culinary and Nutrition Solutions, LLC A tiempo completo

    Patient Services Manager, Hospital Food ServiceBench PositionSalary 63,000.00Patient Services Manager:Be an integral part of the healing process by ensuring food quality, service, safety, and sanitation are provided for all patients. Lead a goal-oriented patient ambassador team to create an environment that is effective and productive, and that takes pride...


  • Hospital de Órbigo, León, España Uniontown Hospital A tiempo completo

    Responsible for the direct and indirect nursing care of the patients in the home. In collaboration with the patient, family, and health care team (IDT), the registered nurse as case manager will develop, implement, and evaluate nursing care according to the following systems/functions.MINIMUM QUALIFICATIONS:EDUCATION, CERTIFICATION, AND/OR LICENSURE:Current...

  • Senior Clinical Scientist

    hace 2 semanas


    Sant Feliu de Llobregat, España Almirall A tiempo completo

    Fecha: 17 jun. 2024- Ubicación: SFEL - R&D SANT FELIU DE LLOBR**Mission**: - The Senior Clinical Development Scientist is an important member of the Global Project Team, Strategic Clinical Team and Clinical Study Teams working cross functionally with other R&D and non-R&D departments such as Regulatory and Patient Safety, Disease Biology, Global Market...