General Description:

This position is work as Associate Manager, Trials Safety Operations and is responsible for driving global operational excellence and manages the safety activities in clinical trial. This includes trial safety related documents preparations, trial study start-up, trial safety training, SAE query management, SAE reconciliation, support trial data clean activities, trial closure activities and trial inspection readiness to ensure trial safety management is compliant with worldwide regulations.

Essential Functions of the job:

•Communicate study project status information; collaborate on project issue identification and resolution; and provide PV technical expertise where needed.

•Assist with line Manager for coordinating/responsible all operational PV tasks generated in clinical trials ensure these trials/projects are carried out according to the relevant quality documents and standards and regulatory requirements.

•Managing safety operation activities in clinical trial globally, including trial safety operation related documents preparation, trial study start-up, trial safety operation training, query management, SAE reconciliation, support trial data clean activities, trial closure activities and global inspection readiness to ensure trial safety operations are continuously met

•Helps prepare and review trial safety operation related documents including but might not limited to the following trial essential documents: trial protocol/protocol amendment, study oversight plan, trail master file plan, study training matrix, SAE reconciliation plan, Case Report Form, study Delegation Letter, Country Specific Reporting Plan, Pharmacovigilance Agreement (for trails that involve business partners)

•Assist in the development of department-specific SOPs and Work Instructions

•As safety operation representative in Clinical Trial Team attend study team meeting

•Support internal and external GPS department trial audits or inspections.

•Support BeiGene ICSR case processing team for trial safety operations related activities including maintain trial status information and trial contact information, SAE reconciliation, query follow up and closure, facilitate IRT access management and study site training

•Support BeiGene Global Patient Safety ICASM team for trial safety operations related activities including Country Specific Reporting Plan preparation, and follow up with Regulatory Affair to make sure trial Health Authorities/ Ethics Committee approval information is accurately maintained in study tracker, follow up with Clinical Operation team to make sure Investigator contact information is updated in a timely manner, and review reporting matrix

•Support BeiGene Safety Systems team for trial safety operations related activities including trial configuration in Argus system, reporting rule and destination confirmation, periodic safety outputs including SAE reconciliation listing, case version report, periodic SUSAR line listing

•Assist in the preparation of trial safety operations training materials, act as a training resource to related personnel

•Assist with line manager to participate in other department projects as needed

Education Required:

•Bachelor’s degree in life sciences, pharmacy, nursing or equivalent health experience

•Advanced Life Sciences Degree

Pharmacovigilance Experience:

• Minimum Five (

5) years or more of experience in pharmacovigilance

• Minimum Two (

2) years of experience with safety operation in pharmacovigilance

Computer Skills:

•Familiar with safety database such as Argus and ArisGlobal, etc.

•Proficient in MS Office Suite (Word, Powerpoint, Excel, Outlook, etc.)

•Experience with clinical database such as Medidata Rave. (preferred)

Other Qualifications:

•Excellent communication skills and ability to prioritize and multitask

•Excellent presentation and training skills

•Fluent in English (both writing and speaking)