天津招聘

Responsibilities:

• Performs medical review of individual case safety reports (ICSR) for clinical and post-market cases, including coding, seriousness, expectedness, and causality assessments and within workflow timelines and per ICH-GCP guidelines, regulatory requirements and company’s SOPs. Provides appropriate judgement with medical assessment to adverse event cases, if applicable.
• Performs quality control review of all SAE cases to ensure medical accuracy, integrity and completeness of information reported and entered in the safety database.
• Performs routine surveillance review and evaluation of safety aggregate data as part of routine and ad-hoc signal detection activities and contributes to the development of risk management plans. Provides medical opinions for clinical trial SAE reports, including SUSAR report identification.
• Participates in safety data review process, including review of ICSRs and aggregate data.
• Maintain knowledge of global regulatory authority regulations (FDA, EMA and NMPA, etc.) and apply appropriately to all activities.
• Contributes to development of strategy, review, and reporting of drug safety information to regulatory authorities, including but not limited to ICSRs, annual report and periodic or developmental safety update reports (DSURs).
• Provides guidance and review of safety section (s) of study documentations such as protocols, IBs, forms, IB/DCSI updates, etc.
• Interacts with business stakeholders, CROs, etc., for assigned products and clinical programs and participates in meetings for different clinical programs. Responds to safety related queries from agents, partners, etc.
• Contribute to the training, and continuing education for all departmental staff.

Qualifications

• MD with at least 10 years of biotech/pharmaceutical industry experience, including at least 5 years of experience in clinical safety/PV

• Solid knowledge of US and China drug safety regulations.
• In depth knowledge of global clinical and post-marketing safety regulations and reporting process.
• Knowledge and experience of safety surveillance, signal detection, labeling analyses, and ad hoc safety analyses.
• In depth knowledge of Good Pharmacovigilance Practices (GPP)

• In depth knowledge of Good Clinical Practices (GCP) related to clinical trial safety documentation and reports
• Demonstrated experience with development, authorship and review of aggregate reports (PSUR, ASR, IND annual, NDA annual etc.), Risk Management Plans, and Risk Evaluation and Mitigation Strategies

• Demonstrated great writing skills (published medical or scientific papers) in Chinese and English. A great communicator.

Competencies:

• Working knowledge of ICH/GCP, US and Chinese regulatory requirements
• Ability to communicate ideas, solutions, and standards
• Read, understand English
• Ability to identify inefficiencies, assist in determining root causes and provide recommended solutions to challenges
• Efficient time-manager able to handle the pressure of meeting multiple strict deadlines
• Self-driven individual able to function with minimal supervision
• Proficient with MS Office products and other technology tools
• Travel as needed, but not expected to exceed 15%

上海科州药物研发有限公司于2014年注册成立，是一家研发型的高科技新药创制企业，是上海市重点扶持的生物医药研发企业。公司位于上海张江药谷，主要从事自有自主知识产权的新药的研发和新工艺的研发。公司团队特点是以在美留学工作多年、研发经验丰富的归国科学家为核心，以博士和硕士为主体的研发团队。迄今为止，公司已经申请国际发明专利一篇，国内专利近二十篇。公司凭借着在新药研发方面的成绩和优势，得到大型跨国制药企业的战略投资。

公司提供一流的新药研发条件，为有志于从事新药研发的人员提供广阔的发展平台。现由于发展需要，诚聘新药研发各方向研究和管理人员，我们期待您的加入。