Pharmacoepidemiology Scientist

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募集要項

会社概要

同社はグローバル規模の医薬品・臨床研究の企業です。

業務内容

Responsible to lead safety observational studies as scientific lead and to deliver deliverables 

•  Responsible as a study owner of regulatory mandatory safety studies under GPSP (Good Post-Marketing Surveillance Practice) 
•  Demonstrate scientific leadership in safety observational studies, and ensure scientific level of study deliverables from pharmacoepidemiology perspective. 
• Define research questions, develop study design including statistical analysis plan based on research questions, evaluate and interpretate data (analyze in some cases) 
• Review and develop study report/publications. 
• Lead scientific discussion in cross functional team and in discussion with regulatory agency. 
• Collaborate effectively with global and Japan relevant functions and external partners (investigator, CROs) so as to deliver valuable evidence. 

Support non-regulatory mandatory safety observational studies 

• Provide pharmacoepidemiology expertise to support non-regulatory mandatory safety studies. 
• Engage in study protocol, study report/publication development and ensure scientific quality from safety perspective in collaboration with relevant stakeholders. 

Demonstrate pharmacoepidemiology expertise in safety related activities through product lifecycle 

• Provide pharmacoepidemiology expertise to support compounds in development, new product launches, and existing marketed products. 
• Contribute to Japan Risk Management Plan (RMP) development, periodic report development. 
• Review and develop query response to regulatory authority. 
• Demonstrate knowledge of relevant global and local regulatory requirements and practices 
• Understand the roles & responsibilities of the EU Qualified person for Pharmacovigilance (QPPV) and support QPPV to enable to fulfill all QPPV legal responsibilities. 

Contribute to organizational RWE capability development 

•  Act as subject matter expert in the development and maintenance of the Safety Quality System and training tools/programs as they relate to pharmacoepidemiology. 
• Provide pharmacoepidemiology related trainings. 
• Support system/process development to enhance productivity or increase scientific quality. 
• Obtain up-to-date pharmacoepidemiology approach/knowledge 

 

応募条件

Minimum Qualification Requirements: 

• A PhD or DrPH in epidemiology or other related subject with high epidemiologic content; or Master in Epidemiology with at least 2 years in conducting epidemiological studies. 
• Ability to conduct epidemiology research including preparation of study protocols and statistical analysis plans. 
• Competent in the interpretation of the study results 
• Excellent computer skills 
• Strong oral and written communication skills in English　 
• Business level English & Native level Japanese 
• Strong interpersonal and leadership skills 
• Able to work independently and as a team member to resolve a variety of drug safety issues. 

Other Information/Additional Preferences: 

• Clinical background (e.g., PharmD, MD, RN) 
• Technical language skill in Japanese  
• High-level knowledge of relevant regulations with respect to drug safety and adverse event reporting 
• High-level knowledge and good understanding of GPS policies 
• Knowledge of R, SAS, SPSS, and/or equivalent statistical software package, and have analytic skill 

給与

800 - 1400 万円

勤務地

東京