■Sr Medical Safety Advisor

【求人No NJB2306057】
・ Provide PV and risk management expertise to internal and externalcustomers
・ Safety expert for product
・ Maintain knowledge of product product environment and recent literature
・ Maintain PV expertise and understanding of international safety regulations and guidelines
・ Lead cross functional Safety Management Teams （SMTs） and some Global Pharmacovigilanceinternal team（s）
・ Communicate with and represent PV position within project/product teams with external partners
key opinion leaders and Health Authorities and during internal and external negotiations
・ Provide strategic and proactive safety input into development plans
・ Support due diligence activities and pharmacovigilance agreements
・ Responsible for signal detection and analysis
・ Collaborate with Center of Excellence for Signal Detection and Data Mining and SafetyEpidemiology group
・ Identify and implement proactive safety analysis strategies to further define the safety profile forboth marketed products and products in development
・ Lead aggregate safety data review activities and coordinate safety surveillance activities
・ Participate in safety governance process including presentation of safety analyses

■勤務時間
週20時間勤務（目安）
※上記就業時間は目安、週20時間勤務を予定しており、詳細は各自の状況に応じて調整いたします

■勤務地
・自宅/リモートベース

【必須】
・医師免許
・CRO・製薬企業等での事業会社での就業経験
・英語力（読み・書き・スピーキング）