Drug Safety Specialist

hace 2 semanas

Barcelona, Barcelona, España Tfs Healthscience A tiempo completo
About this role

Tfs Healthscience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions.

Key responsibilities
  • Handling of SAEs in clinical trials and spontaneous reports from the market, ensuring collection, assessment, and entry into the safety database in accordance with Tfs/clients' SOPs and existing demands of authorities.
  • Review and approval of processed cases and AE/SAE reconciliation.
  • Coding of adverse events, medical history, and concomitant medication according to MedDRA and WHO-Drug Dictionary.
  • QC and approval of coding of adverse events, medical history, and concomitant medication.
  • Review and write the safety section in clinical study protocols.
  • Review of clinical trial reports/IBs from a safety perspective.
  • Write the safety parts in the PSUR/PBRER, DSURs, IND, NDA, and other safety documents.
  • Literature search.
  • Electronic reporting to EudraVigilance.
  • Contribute to plans/instructions and SOPs for post-approval surveillance.
  • Updating of templates for safety handling in specific studies/projects according to relevant SOPs.
  • May act as a Project Lead for Safety-only projects.
  • Participate in relevant meetings. Forward information to relevant members of the department or study team members.
  • Provide internal support to other relevant departments.
  • Involved in improvement projects with other relevant departments.
  • Actively contribute to the organization and development of routines to enhance the work at Tfs.
  • Validation of computer applications specific for the department with respect to drug safety requirements.
  • Being well-informed and updated on laws, directives, and guidelines concerning handling and reporting of SAEs in clinical trials and serious as well as non-serious events from the market (pharmacovigilance) and other safety issues.
  • Education and supervision of new Drug Safety personnel.
  • Participate in marketing activities.
Requirements
  • Bachelor's Degree, preferably in life science or nursing; or equivalent.
  • 3 years of experience in the position.
  • Able to work in a fast-paced environment with changing priorities.
  • Understand the medical terminology and science associated with the assigned drugs and therapeutic areas.
What We Offer

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patients.

A Bit More About Us

Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future.

  • Drug Safety Specialist

    hace 7 días

    Barcelona, Barcelona, España Tfs Healthscience A tiempo completo

    About Tfs HealthscienceTfs Healthscience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey.We offer full service-capabilities, resourcing and functional service (FSP) solutions.Job SummaryWe are seeking a highly skilled Drug Safety...

  • Technical Drug Safety Officer

    hace 2 semanas

    Barcelona, Barcelona, España Instituto Grifols Sa A tiempo completo

    Join Our Team as a Technical Drug Safety OfficerWe are seeking a highly skilled Technical Drug Safety Officer to join our international team at Instituto Grifols Sa. As a key member of our pharmacovigilance team, you will play a crucial role in ensuring the highest quality of safety data and compliance with global regulatory requirements.Key...

  • Technical Drug Safety Officer

    hace 2 semanas

    Barcelona, Barcelona, España Instituto Grifols Sa A tiempo completo

    Join Our Team as a Technical Drug Safety OfficerWe are seeking a highly skilled Technical Drug Safety Officer to join our international team at Instituto Grifols Sa. As a key member of our pharmacovigilance team, you will play a crucial role in ensuring the highest quality of safety data and compliance with global regulatory requirements.Key...

  • Technical Drug Safety Officer

    hace 2 semanas

    Barcelona, Barcelona, España Instituto Grifols Sa A tiempo completo

    Job Title: Technical Drug Safety OfficerGrifols is a global healthcare company that has been improving the health and well-being of people around the world since 1909. We are leaders in plasma-derived medicines and transfusion medicine, and we develop, produce, and market innovative medicines, solutions, and services in over 110 countries and regions.We...

  • Technical Drug Safety Officer

    hace 2 semanas

    Barcelona, Barcelona, España Instituto Grifols Sa A tiempo completo

    Job Title: Technical Drug Safety OfficerGrifols is a global healthcare company that has been improving the health and well-being of people around the world since 1909. We are leaders in plasma-derived medicines and transfusion medicine, and we develop, produce, and market innovative medicines, solutions, and services in over 110 countries and regions.We...

  • Technical Drug Safety Officer

    hace 2 semanas

    Barcelona, Barcelona, España Grifols A tiempo completo

    Join Grifols as a Technical Drug Safety OfficerWe are seeking a highly skilled Technical Drug Safety Officer to join our international team at Grifols, a global healthcare company dedicated to improving the health and well-being of people around the world.About the RoleAs a Technical Drug Safety Officer, you will be responsible for providing operational...

  • Technical Drug Safety Officer

    hace 2 semanas

    Barcelona, Barcelona, España Grifols A tiempo completo

    Join Grifols as a Technical Drug Safety OfficerWe are seeking a highly skilled Technical Drug Safety Officer to join our international team at Grifols, a global healthcare company dedicated to improving the health and well-being of people around the world.About the RoleAs a Technical Drug Safety Officer, you will be responsible for providing operational...

  • Clinical Safety Specialist

    hace 1 mes

    Barcelona, Barcelona, España TFS HealthScience A tiempo completo

    Unlock Your Potential as a Clinical Safety SpecialistAt TFS HealthScience, we're seeking a highly skilled Clinical Safety Specialist to join our team in Barcelona. As a key member of our Safety, Risk, and Surveillance (SRS) team, you'll play a vital role in ensuring the safety of our clients' clinical trials.About the RoleCollect, assess, and enter safety...

  • Clinical Safety Specialist

    hace 1 mes

    Barcelona, Barcelona, España TFS HealthScience A tiempo completo

    Unlock Your Potential as a Clinical Safety SpecialistAt TFS HealthScience, we're seeking a highly skilled Clinical Safety Specialist to join our team in Barcelona. As a key member of our Safety, Risk, and Surveillance (SRS) team, you'll play a vital role in ensuring the safety of our clients' clinical trials.About the RoleCollect, assess, and enter safety...

  • Drug Safety Team Leader

    hace 2 semanas

    Barcelona, Barcelona, España Insud Pharma A tiempo completo

    Job Title: Drug Safety Team LeaderAt Insud Pharma, we are seeking a highly skilled and experienced Drug Safety Team Leader to join our team. As a key member of our Pharmacovigilance department, you will be responsible for ensuring legal and regulatory compliance with pharmacovigilance regulations and Good Pharmacovigilance Practices (GVP).Key...

  • Drug Safety Team Leader

    hace 2 semanas

    Barcelona, Barcelona, España Insud Pharma A tiempo completo

    Job Title: Drug Safety Team LeaderAt Insud Pharma, we are seeking a highly skilled and experienced Drug Safety Team Leader to join our team. As a key member of our Pharmacovigilance department, you will be responsible for ensuring legal and regulatory compliance with pharmacovigilance regulations and Good Pharmacovigilance Practices (GVP).Key...

  • Clinical Safety Specialist

    hace 2 semanas

    Barcelona, Barcelona, España Tfs Healthscience A tiempo completo

    Job Title: Clinical Safety SpecialistAt Tfs Healthscience, we are seeking a highly skilled Clinical Safety Specialist to join our team. As a key member of our Safety and Regulatory Services (SRS) team, you will be responsible for ensuring the safe and effective handling of clinical trials and post-marketing surveillance.Key Responsibilities:Review and...

  • Clinical Safety Specialist

    hace 2 semanas

    Barcelona, Barcelona, España Tfs Healthscience A tiempo completo

    Job Title: Clinical Safety SpecialistAt Tfs Healthscience, we are seeking a highly skilled Clinical Safety Specialist to join our team. As a key member of our Safety and Regulatory Services (SRS) team, you will be responsible for ensuring the safe and effective handling of clinical trials and post-marketing surveillance.Key Responsibilities:Review and...

  • Clinical Safety Specialist

    hace 1 semana

    Barcelona, Barcelona, España Tfs Healthscience A tiempo completo

    About this roleTfs Healthscience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey.We offer full service-capabilities, resourcing and functional service (FSP) solutions.Key responsibilitiesHandling of Serious Adverse Events (SAEs) in...

  • Senior Risk Management Specialist, Global Patient Safety

    hace 3 días

    Barcelona, Barcelona, España Https:Www.Energyjobline.ComSitemap A tiempo completo

    Key Responsibilities:As a Senior Risk Management Specialist, Global Patient Safety, you will play a critical role in evaluating and managing risk within the Global Patient Safety (GPS) team. You will collaborate with the GPS Medical Director(s) and cross-functional team members to ensure compliance with the global regulatory framework.Key...

  • Clinical Safety Specialist

    hace 2 semanas

    Barcelona, Barcelona, España Tfs Healthscience A tiempo completo

    About this roleTfs Healthscience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions.Key ResponsibilitiesHandling of Serious Adverse Events...

  • Clinical Safety Specialist

    hace 2 semanas

    Barcelona, Barcelona, España Tfs Healthscience A tiempo completo

    About this roleTfs Healthscience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions.Key ResponsibilitiesHandling of Serious Adverse Events...

  • Technical Drug Safety Officer

    hace 4 días

    Barcelona, Barcelona, España Grifols A tiempo completo

    We are seeking a highly skilled Technical Drug Safety Officer to join our international team at Grifols, a global healthcare company dedicated to improving the health and well-being of people around the world.As a Technical Drug Safety Officer, you will provide operational support for global pharmacovigilance activities, ensuring the highest quality...

  • Technical Drug Safety Officer

    hace 2 semanas

    Barcelona, Barcelona, España Grifols A tiempo completo

    Join Grifols as a Technical Drug Safety OfficerGrifols is a global healthcare company that has been improving the health and well-being of people around the world since 1909. We are leaders in plasma-derived medicines and transfusion medicine, and we develop, produce, and market innovative medicines, solutions, and services in over 110 countries and...

  • Technical Drug Safety Officer

    hace 2 semanas

    Barcelona, Barcelona, España Grifols A tiempo completo

    Join Grifols as a Technical Drug Safety OfficerGrifols is a global healthcare company that has been improving the health and well-being of people around the world since 1909. We are leaders in plasma-derived medicines and transfusion medicine, and we develop, produce, and market innovative medicines, solutions, and services in over 110 countries and...