Description
We are seeking a Clinical Safety and PSS Operations Assistant to support our operations in Tokyo. The successful candidate will assist with the overall Clinical Safety and/or PSS operations associated with products, including the entire adverse events process.
The role involves managing and processing expeditable adverse events to the required standard and submitting them to clients and regulatory agencies within agreed timelines. The ideal candidate will have a strong understanding of safety database conventions, regulatory requirements, and pharmacovigilance.
Responsibilities:
- Manage the receipt and processing of all adverse event reports
- Review adverse events for completeness, accuracy, and appropriateness for expedited reporting
- Write patient narratives and code adverse events accurately using MedDRA
- Determine listedness against the appropriate label
- Identify clinically significant information missing from reports and ensure its collection and follow-up
- Ensure all cases that require expediting reporting to worldwide Regulatory Agencies and other required parties are processed swiftly and appropriately
- Perform database reconciliation with Data Management team or sponsor/client as needed
- Participate in signal detection and trend and pattern recognition activities
- Assist in the preparation of listings for Annual IND reports, Periodic Reports, and other safety-related documents
- Support and train less experienced safety staff
- Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents, and directives associated with safety management, reporting, and pharmacovigilance
Qualifications:
- Non-degree + 2 years of Safety experience or 4-5 years of relevant experience
- Associate degree + 2 years of Safety experience or 3-4 years of relevant experience
- BS/BA + 1-2 years of Safety experience or 2-3 years of relevant experience
- MS/MA + 1-2 years of Safety experience or 2 years of relevant experience
- PharmD + 1-2 years of Safety experience or 2 years of relevant experience
- Degree preferred in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area
Experience:
- High degree of accuracy with attention to detail
- Functions as a team player
- Good communication and presentation skills
- Knowledge of medical and drug terminology desirable
- Familiarity with Good Clinical Practice (GCP) related to clinical safety documentation
- Familiarity with ICH Guidelines
- Ability to work independently with minimal supervision
- Good keyboard skills, preferably with knowledge of MS Office and Windows
Physical Demands/Work Environment:
- Office environment
- Available for travel 5% of the time, including overnight stays, as necessary