Opening for Drug Safety Associate in Parexel - B.Phram/B.Sc
PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.
Post: Drug Safety Associate
The Drug Safety Associate will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).
Reports To Regional Head of PV Operations/ Associate Team Manager PV Operations
Directly Supervises None
Provides Work Direction to Drug Safety Assistants
Works Closely with All Medical and PV staff, Project Management and members of the Clinical Operations Group
External Relationships Clients, Healthcare Professionals, Consumers, Consumer Representatives
• Triage of incoming reports for completeness, legibility and validity
• 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
• Understanding of drug safety and the drug development process
• Analytical and problem solving skills
• Excellent interpersonal skills
• Excellent verbal / written communication skills
• Time management skills
• Team player
• Client focused approach to work
• Experience with basic computer applications
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