Asst/Associate Drug Safety (Japanese)

Job Overview:Assist in or complete per the Safety Management Plan (SMP) the processing of all adverse event reports from any source. Assist in producing queries of safety data for clients as appropriate. Assist in the generation and maintenance of the PV&DSS metrics. Assist Data Management or clients on reconciliation of safety databases. Provide input for monthly status reports. Maintains a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance. Possess knowledge of other procedural documents, e.g., SOPs, and how they impact safety. Build and maintain good PV&DSS relationships across functional units. Demonstrate role-specific Core Competencies on a consistent basis. Demonstrate company Values on a consistent basis. Assist in the preparation of client meetings and liaise with clients where appropriate. Assist with the set-up of, and the provision of data to, Safety Committees/DSMBs. Any other duties as assigned by management. Education/Qualifications:Required: Non-degree + 4-5 yrs relevant experience (or 2 yrs safety experience)* Associates Degree + 3-4 yrs relevant experience (or 1-2 yrs safety experience)* Associate degree RN + 2-3 yrs relevant experience (or 1-2 yrs safety experience)* BS/BA + 1-2 yrs relevant experience** MS/MA + 0 yr relevant experience** PharmD + 0 yrs relevant experience**

Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.

*Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.

**Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance. Experience:Required: High degree of accuracy with attention to detail. Functions as a team player. Good Communication. Knowledge of medical and drug terminology desirable. Familiarity of Good Clinical Practice (GCP) related to clinical safety documentation. Familiarity with ICH Guidelines Familiarity of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products. Familiarity of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products. Good written and verbal communication skills. Ability to work independently with moderate supervision. Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.