PRAHS

Returning Candidate?

2018-44535

2018-44535

Title 
Drug Safety Associate 2
Job Locations 
-
Brazil-Sao Paolo
Posted Date 
1/9/2018

More information about this job

Overview

Provides management of individual case safety reports (SAEs, ADRs, AEs of special interest and other types), reconciliation of SAEs, coding and data retrievals from the safety database. Supports the generation of aggregated safety reports, and Data Monitoring Committees (DMC) reviews.

Responsibilities

  • Applies considerable knowledge of PRA's policies and procedures
  • Applies knowledge of computerized information systems and standard application software (Windows, MS Office)
  • Applies knowledge of working in safety databases
  • Applies knowledge in pharmacovigilance
  • Develops project specific technical and planning documents in own functional area
  • Has limited knowledge in managing project budgets

Qualifications

  • In addition to the above:
    • 2-3 years experience in processing of ICSR and/or
    • 2-3 years experience as a Clinical Data Coordinator, with at least one year experience as Lead Clinical Data Coordinator



  • Undergraduate degree or its international equivalent, preferably in life science and/or healthcare professional.


  • Knowledge in pre- and post-marketing Pharmacovigilance. Basic knowledge of regulatory environment governing safety and risk management activities.




PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

Options

Share on your newsfeed

Connect With Us!

Not ready to apply? We get it! Click here to stay in touch for future opportunities, events and other happenings!