Specialist II, Patient Safety Solutions

4 meses atrás


São Paulo, Brasil SAO Fortrea Brazil Limitada Tempo inteiro

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Summary of Responsibilities:

Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports).

Manage and process expendable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines.The post holder is responsible for providing this service to clients either as a support function to the client project groups or as stand-alone business.

Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.

He/she will be expected to comply with the legal requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health & Safety Manual.

Main requirements:

Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area. Previous experience with general pharmacovigilance activities (case processing, regulatory submissions, among others) Previous experence case processing quality control Fluent English and Intermediate Spanish General MS Office knowledge Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation. Knowledge of ICH Guidelines Knowledge of Medical Device reporting desirable Good verbal and written communication skills and good presentation skills. Ability to interact and influence with line and middle management, staff, and external contacts on a functional and tactical level. High degree of accuracy with attention to detail Functions as a team player

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.


  • Clinical Safety Specialist

    1 semana atrás


    São Paulo, São Paulo, Brasil Fortrea Tempo inteiro

    Job SummaryFortrea is seeking a highly skilled Clinical Safety Specialist to join our team in Sao Paulo, Brazil. As a Clinical Safety Specialist, you will play a critical role in ensuring the safety of our clients' products and patients.Key ResponsibilitiesManage and process expedited adverse events to the required standard and submit them to the client...


  • São Paulo, São Paulo, Brasil SAO Fortrea Brazil Limitada Tempo inteiro

    **Job Summary:**SAO Fortrea Brazil Limitada is seeking a highly skilled Clinical Safety Specialist II to join our team. As a leading global contract research organization, we provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic...


  • São Paulo, São Paulo, Brasil SAO Fortrea Brazil Limitada Tempo inteiro

    **Job Summary:**SAO Fortrea Brazil Limitada is seeking a highly skilled Clinical Safety Specialist II to join our team. As a leading global contract research organization, we provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic...


  • Sao Paulo, Brasil Fortrea Tempo inteiro

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...


  • São Paulo, Brasil SAO Fortrea Brazil Limitada Tempo inteiro

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...


  • São Paulo, Brasil SAO Fortrea Brazil Limitada Tempo inteiro

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...


  • São Paulo, São Paulo, Brasil SAO Fortrea Brazil Limitada Tempo inteiro

    Job Title: Clinical Safety SpecialistSAO Fortrea Brazil Limitada is seeking a highly motivated Clinical Safety Specialist to join our team. As a Clinical Safety Specialist, you will play a critical role in ensuring the safety of our clients' products and adhering to regulatory requirements.Key Responsibilities:Perform case intake and triage of incoming...

  • Clinical Safety Specialist

    2 semanas atrás


    São Paulo, São Paulo, Brasil SAO Fortrea Brazil Limitada Tempo inteiro

    **Job Summary:**SAO Fortrea Brazil Limitada is seeking a highly skilled Clinical Safety Specialist to join our team. As a Clinical Safety Specialist, you will be responsible for assisting with the overall Clinical Safety and/or Patient Safety Solutions operations associated with products.**Key Responsibilities:**Manage and process adverse events to the...


  • São Paulo, São Paulo, Brasil SAO Fortrea Brazil Limitada Tempo inteiro

    Job SummarySAO Fortrea Brazil Limitada is seeking a highly skilled Clinical Safety Specialist to join our team. As a key member of our Clinical Safety and Patient Safety Solutions operations, you will play a critical role in ensuring the safety and efficacy of our products.Key ResponsibilitiesManage and process adverse events to the required standard and...

  • Assistant I

    4 meses atrás


    São Paulo, Brasil SAO Fortrea Brazil Limitada Tempo inteiro

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...


  • Sao Paulo, Brasil Fortrea Tempo inteiro

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...


  • São Paulo, São Paulo, Brasil SAO Fortrea Brazil Limitada Tempo inteiro

    Transforming Clinical Trials with FortreaAs a leading global contract research organization, Fortrea is dedicated to delivering innovative solutions for pharmaceutical, biotechnology, and medical device customers. We are seeking a highly motivated and detail-oriented individual to join our team as a Clinical Safety Specialist.Key Responsibilities:Manage and...

  • Clinical Safety Specialist

    2 semanas atrás


    São Paulo, São Paulo, Brasil SAO Fortrea Brazil Limitada Tempo inteiro

    As a leading global contract research organization (CRO), SAO Fortrea Brazil Limitada provides pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.Our team is responsible for assisting with the overall Clinical Safety and/or...


  • Sao Paulo, Brasil AstraZeneca Tempo inteiro

    AstraZeneca is one of the most fascinating biopharmaceutical companies in the world. From researchers to sales people, from lab technicians to the legal department, we all have a mission to turn ideas into science, science into revolutionary medicines that save and extend patients’ lives and benefit society. Our portfolio is solid and our pipeline is...


  • Sao Paulo, Brasil Motorola Solutions Tempo inteiro

    **Company Overview**: At Motorola Solutions, we're guided by a shared purpose - helping people be their best in the moments that matter - and we live up to our purpose every day by solving for safer. Because people can only be their best when they not only feel safe, but are safe. We're solving for safer by building the best possible technologies across...

  • EHS Specialist

    3 meses atrás


    Sao Paulo, Brasil Motorola Solutions Tempo inteiro

    **Company Overview**: At Motorola Solutions, we believe that everything starts with safety. It’s the constant that empowers people to confidently move forward. It can fill a flight or sell out a stadium. It can care for a patient or graduate a class. As a global leader in public safety and enterprise security, we create and connect the technologies that...


  • São Paulo, São Paulo, Brasil SAO Fortrea Brazil Limitada Tempo inteiro

    Job SummaryAs a leading global contract research organization, SAO Fortrea Brazil Limitada provides pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across multiple therapeutic areas.Key ResponsibilitiesAssist with overall Clinical Safety and/or PSS operations...

  • Associate I

    3 meses atrás


    Sao Paulo, Brasil Fortrea Tempo inteiro

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • EHS Safety Specialist

    3 meses atrás


    Sao Paulo, Brasil Olin Tempo inteiro

    Join our winning team as an **EHS Safety Specialist **in our **EH&S **Department** at Guarujá, Brazil. In this role, you will actively participate in all aspects of Security within the Olin organization and stakeholders. **EHS Safety Specialist Essential Functions** - Implements health and safety management systems (processes, standards and regulations). -...


  • São Paulo, São Paulo, Brasil Luxoft Tempo inteiro

    About the RoleWe are seeking a highly skilled Automotive Functional Safety Specialist to join our team at Luxoft.As a key member of our team, you will be responsible for ensuring the safety and reliability of our automotive systems.Key ResponsibilitiesDevelop and implement functional safety strategies for automotive systemsCollaborate with cross-functional...