Patient Safety Project Manager

4 semanas atrás

Cidade Jardim, Brasil Labcorp 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.
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Job Summary:
 Manage ‘Client’ or ‘Project’ specific 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) for specified projects.
 Manage and process expeditable 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.
 Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.
**Experience**:
Required:
 Compliance with client and global regulatory requirements
 Good knowledge of the relevant worldwide pharmacovigilance regulations and guidelines.
 Good knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
 Good knowledge of ICH guidelines.
 Good knowledge of medical and drug terminology
 Work collaboratively with PSS Management’s team
 Good verbal, written and presentation skills.
 Good communication.
 Leadership capabilities
 Anticipate/identify problems and takes appropriate action to correct.
 Knowledge of Medical Device Reporting desirable
 Knowledge of aggregate reporting
 Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.
 Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
 Financially intuitive
Education/Qualifications/Certifications and Licenses
Minimum Required:
 Level of education required (or experience level which may be substituted for level of education). Professional designations/certifications/licenses required
 Non-degree + 6-7 yrs Safety experience
 Associate degree + 5-6 yrs Safety experience
 Associate degree RN + 5-6 yrs Safety experience
 BS/BA + 4-5 yrs Safety experience
 MS/MA + 3-4 yrs relevant experience** or 2-3 yrs Safety experience
 PharmD + 2-3 yrs relevant experience** or 1-2 yrs Safety experience
**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp 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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