Pharmacoepidemiology Scientist

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Job details

Company overview

Our client is one of the top medicine and Clinical Research companies worldwide.

Responsibilities

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 

 

Requirements

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 

Salary

8 - 14 million yen

Location

Tokyo