Drug Safety Associate
Posted on 14 Feb 2014
Requisition # pare-10031718
Location India - Andhra Pradesh - Hyderabad
Location Hyderabad
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).
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
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
Requisition # pare-10031718
Location India - Andhra Pradesh - Hyderabad
Location Hyderabad
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).
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
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
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