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.

• Medical Information Contact Centre Associate II, Patient Safety Services – German and Italian Speaker

  • Are you a fluent German and Italian speaker who is looking for a fresh challenge in Patient Safety within a global CRO?

  • Are you interested in playing a key role in handling and discussing medical information with clients/patients, in a contact center environment, whilst working from home?

  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.

  It is essential you have a health care related degree/background and ideally some experience working in with medical information in a hospital/pharmacy environment. You will have the opportunity to work 100% remote and progress your career in patient safety.

  Due to continuous growth, the Patient Safety Solutions (PSS) team is looking to hire an Associate II PSS. You will be responsible for assisting with overall running of the PSS Department associated with the entire adverse (AE) event process, which will include data taken from post marketing settings. You will manage and process expeditable AEs to required standards and submit them to the client and regulatory agencies.

  Language Skills Required:

  Fluency in German and Italian - Native or C1 Certificate

  
  Duties and Responsibilities:

  • Manage the receipt and processing of all AE reports. Including: data entry of safety data, review of AEs, writing patient narratives, submission of SAE reports to clients and regulatory agencies etc.

  • Assist in the generation and maintenance of the PSS metrics

  • Assist Data Management or clients on reconciliation of Medical information databases

  • Manage processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission

  • Perform quality review or peer review of processed reports and support the Line Management with trends and actions needed

  • Maintains a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance

  • Assist in the generation and maintenance of the PSS metrics

  • Support preparation for client meetings and liaise with clients where appropriate.

  • Assist with the set-up of, and the provision of data to Safety Committees/DSMBs as applicable

  • Support and/or participate in audits and inspections including the preparation, as needed

  • Demonstrate role-specific Core Competencies and company values on a consistent basis

  • Build and maintain good PSS relationships across functional units

  Experience Required:

  • High degree of accuracy with attention to detail.

  • Functions as a team player.

  • Good communication.

  • Good written and verbal communication skills.

  • Ability to work independently with moderate supervision.

  Education/Qualifications/Certifications and Licenses

  • Non-degree + 2 yrs safety experience * or 3-4 yrs relevant experience**    

  • Associate Degree + 2 yrs safety experience* or 2-3 yrs relevant experience**    

  • BS/BA + 1 year of Safety experience* or 2 yrs of relevant experience**    

  • Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.  

  • Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance

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. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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