Drug Safety Associate
Job Title Drug Safety Associate
Department Worldwide Medical Services
SBU Clinical Research Services (CRS)
Location Bengaluru
Department Worldwide Medical Services
SBU Clinical Research Services (CRS)
Location Bengaluru
Essential Function
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).
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).
Relationships
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
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
Key Accountabilities
• 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:
o collection and review of endpoint packages
o review and follow-up laboratory alerts
o review and follow-up patient eligibility for inclusion / exclusion in clinical trials
o review and follow-up protocol violations
o 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
• 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:
o collection and review of endpoint packages
o review and follow-up laboratory alerts
o review and follow-up patient eligibility for inclusion / exclusion in clinical trials
o review and follow-up protocol violations
o 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
Skills
• 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
Education (one of:)
• 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
• 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
Education (one of:)
• 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
1 comments:
The duties of the drug safety associate are discussed in this article. Aside from making sure that all applicable laws, Standard Operating Procedures (SOPs), and Key Accountabilities are followed—such as triaging incoming reports for accuracy, validity, and completeness—the Drug Safety Associate will also oversee medical monitoring and drug safety management (clinical trials and post-marketing).