Wednesday, April 11, 2012

Job Opening for Drug Safety Specialist in Parexel

There are opening for Drug Safety Associate in Parexel International. The details are as follows :

Title              : Drug Safety Specialist
Location       : Hyderabad, Andhra Pradesh, India 
Department  : Pharmacovigilance

  • Degree in Pharmacy, Nursing, Life Science, or other health-related field , or equivalent qualification 
  • Associates/diploma degree in any of the above with appropriate work experience
Skills & Experience 
  • Sound knowledge of drug safety and the drug development process 
  • Knowledge of and ability to interpret and apply global safety regulations. 
  • Experience in data analysis and evaluation of safety data
  • Demonstrated competence in processing, evaluating and reporting safety information in compliance with the regulations
  • Good presentation skills
  • Excellent interpersonal skills
  • Excellent verbal / written communication skills
  • Good time management skills
  • Team player
  • Client focused approach to work 
  • Experience with computer applications including database management and pharmacovigilance related computing systems
  • Drug safety knowledge and experience in Safety Database
 Job Profile
  • Initial data entry of case reports into safety database / tracking system 
  • Assessment of case reports for seriousness, causality and expectedness
  • Requesting follow-up i.e. written, telephone
  • Adverse event (AE) and drug coding
  • Writing case narratives
  • Create and maintain project specific working files, case report files and project central files
  • Assist with additional Drug Safety Specialist activities as required
  • Inform Medical Project Managers and Regional Head of PV Operations of potential change-in-scope of projects
  • Work with Medical Directors/Safety Physicians, as needed, with medical monitoring activities such as:
  • collection and review of endpoint packages
  • review and follow-up laboratory alerts
  • review and follow-up patient eligibility for inclusion / exclusion in clinical trials
  • review and follow-up protocol violations
  • review study specific Model ICFs according ICH/GCP criteria
  • Participate in client meetings / investigator meetings / project specific training sessions 
  • Delegate work as appropriate to Drug Safety Assistants
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