上海招聘

工作职责

• Ensure timely handling individual cases (including SAE and SUSAR) in clinical trials for full compliance of related China regulation, and communicate with site staff as appropriate. Provide medical assessment of individual cases when needed.

• Provides scientific safety input into key safety related deliverables including regular safety profile summary, aggregate safety reports (e.g., Periodic Safety Update Report), Risk Management Plan, Risk Control Plan, etc..

• Support to perform frequent safety review activities in clinical trials.

• Oversight outsourcing pharmacovigilance activities when needed.

• Supports the communication on safety topics with the CNDA, KOLs and other external stakeholders..

• Respond safety queries from internal stakeholders.

• Provides drug safety support as needed for licensing activities, regulatory authorities inspections and other projects.

• Provide pharmacovigilance training to cross functional team.

  任职资格

• Medical or pharmacology bachelor degree, or above.

• At least 2 years of medical/clinical/drug safety experience in pharmaceutical company. Clinical experience is preferred.

• Fluent English communication.

科济生物简介

科济生物医药（上海）有限公司（以下简称“科济生物”）是聚焦于CAR-T细胞、抗体等肿瘤免疫治疗药物的创新型生物医药企业。

科济生物成立于2014年，总部位于上海，在中国和美国设有实体运营中心。目前公司已建立了广泛的CAR-T候选产品研发管线，开发了能够覆盖大部分实体瘤及血液肿瘤的高效特异性CAR-T及抗体药物候选产品，以满足日益增长的医疗需求。公司已率先启动了多项治疗复发/难治性实体瘤的CAR-T临床研究项目，包括针对肝细胞癌（HCC）和肺鳞癌的CAR-GPC3-T项目，CAR-EGFR / EGFRvIII-T试验用于胶质母细胞瘤，CAR-Claudin18.2-T用于胃癌和***癌等的临床研究。目前科济生物已经获得多项国内外的CAR-T细胞新药临床试验许可，其中BCMA CAR T细胞药物还分别获得美国和欧盟药监局的"再生医学先进疗法（RMAT）"和"优先药物（PRIME）"资格。

此外，科济生物还拥有治疗性抗体药物的研发平台，其领先的针对Claudin18.2的人源化单克隆抗体已获得国家药监局（NMPA）的IND批准。

  展望未来，科济生物将秉承“科创济世”的价值观，积极与国内外顶尖研究机构、知名医院合作，推进各种先进治疗手段的研制，从而造福更多肿瘤患者。