A global pharmaceutical company

1. Responsible for epidemiology deliverables for Japan PMS, in coordination with Global Epidemiology, including:
• Post-marketing surveillance strategy, including product portfolio review and protocol strategic support
• Epidemiology studies; post-approval safety database study and the feasibility assessments
• Others; background epidemiology study, natural history of disease study and user characterization study
• Design and implement multiple database research, including the planning and publication
2. Provide epidemiological support for developing and executing strategies for maximizing the medical value of marketed drugs through remainder of the product's lifecycle
3. Develop the pharmacoepidemiology capabilities in Japan
１）疫学的な戦略と研究手法を用いて、医薬品開発の各段階（研究開発の早期から市販後）において 疫学的なサポートを提供する。
２）疫学の側面から担当製品の市販後調査をサポートする。特に2018年4月に改正されたGPSP省令 に対応し、医療情報データベースを利用した市販後データベース調査の計画・立案、実施をサポート する
３）リスクマネジメントプラン（RMP）およびその他の医薬品開発および規制関連活動の研究・調査 をサポートする
４） データベース所有者を含む学術や研究団体の専門家との専門的なコラボレーションをサポートす る

• Master’s degree or comparable in epidemiology, statistics, health services research or related areas (PhD preferred)
• 5+ years of experience in Pharmaceutical Industry/3+ years expert knowledge epidemiologic methods application
• Experience in designing, conducting, analyzing and interpreting epidemiological studies, especially those based on large electronic health records databases
• Computing ability including knowledge of specialized epidemiological/statistical packages
• Strong interpersonal and communication skills bridging scientific and business needs
• Solid knowledge of drug development and HA guidelines, especially as relevant to epidemiological methods

AC-200901-225070