Safety Scientist

Expira em: 6 dias

UBC

United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our diverse suite of services helps bridge the gap between development and delivery and builds brand loyalty through patient access and adherence. UBC is well known for our ability to generate authoritative, real-world evidence of product effectiveness, safety, and value to assist healthcare decisions and enhance patient care. With the strength of our parent company, Express Scripts, one of the nation’s largest healthcare companies, UBC leads the market in providing integrated, comprehensive clinical, safety, and commercialization services.



Nº de Vagas: 1-5 vagas

Tipo: Full-time

Salário(por ano): .

Setor: Farmaceutico

Função: Saude / Medicina

Região: Reino Unido, Suíça






Brief Description:

Responsible for supporting all operational functions within the Safety Department including, but not limited to, client interface and deliverables, Individual Case Safety Report (ICSR) case processing, project start-up, database configuration, literature review, training and contributing to the development and maintenance of departmental Standard Operating Procedures (SOPs) and guidelines.  


Specific Job Duties:

  • Writing of procedural documents such as Adverse Event Reporting Plans (AERPs);
  • Adverse Event case processing: receipt, data entry, coding, and evaluation of Adverse Event reports according to the applicable SOPs, including writing the narrative; perform seriousness, listedness and causality assessment;
  • Ensure the quality and accuracy of data used to support any regulatory document, including but not limited to: ICSRs, aggregate data, requested line listings;
  • Assist in the reconciliation of clinical and safety databases;
  • Monitor compliance and ensure appropriate documentation (metrics, deviations);
  • Assist in evaluation and validation of systems to support safety e.g. supporting the development teams in safety database configuration and EDC specifications;
  • Performing global and local literature review,
  • Project oversight and identification of issues. Escalation.


Requirements:

  • Registered Nurse, Pharmacist, or other Life - Science degree;
  • Comprehensive knowledge of EU, ICH and FDA Regulations and Guidelines both clinical and post marketing;
  • Experience in pre and post marketing Pharmacovigilance;
  • Experience in literature review;
  • Experience in case processing and PV regulatory reporting activities;
  • Experience in data entry in ICH E2B compliant database;
  • Knowledge of database management a plus, 
  • Fluent in English, additional language fluency a plus, but not required.



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