Specialist Ii, Patient Safety Solutions

4 semanas atrás

São Paulo, São 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 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 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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