成都招聘

Key Duties and Responsibilities

? Leadership and organization of the Drug Safety & Pharmacovigilance function and all safety aspects in clinical trials in collaboration with all functions and vendors for all clinical development programs and establish the procedures for post-marketing pharmacovigilance.

? Provides input and responsible for the safety aspects of periodic regulatory safety reports, the Investigator's Brochures, Informed Consents, clinical study protocols, clinical study reports, safety sections of the INDs or IMPDs or other regulatory documents, safety aspects of the CTD modules, and regulatory labels and other documents, including Medical Monitoring plans and Safety Management Plans.

? Develop the budgets and updates and management of contracts for the Pharmacovigilance function with the safety vendors in collaboration with the Head of Project Management, Finance and Core and Clinical Development Team Leaders and other relevant functions.

? Collaborate and oversee the Safety Scientist function.

? Involvement in business development activities and due diligences and working with Business Partners.

? Involved in internal process improvement activities such as SOPs or guidance documents, as assigned.

? Supervise direct reports, including review of performance and working on training needs for further development of the direct reports.

Education and Experience

? MD degree required.

? 10+ years of experience in global clinical safety for development projects and Pharmacovigilance of marketed products.

? Strong leadership and collaborative capabilities for cross functional teams.

? Oncology therapy experience preferred.

? Knowledge of FDA, EMA and NMPA regulations, ICH guidance, and GCP regulations.

Essential Skills and Abilities

? Good organizational skills.

? Excellent communication skills, both verbally and in writing.

? Strong presentation skills, including presentations to senior management, external audiences and experts.

? Ability to work across locations and time zones.

? Ability to work on several projects and assignments at the same time and also prioritize tasks.

? Strong analytical skills.

? Strong interpersonal skills and ability to confront issues with vendors and cross-functional team members for a win-win outcome.

? Thorough understanding of ICH Good Pharmacovigilance Practices and Good Clinical Practices, including broad application of knowledge in different therapeutic areas.

? Knowledge of MedDRA and Argus or similar applications and systems.

? A commitment to collaborative leadership, management, teamwork, delegation and the maintenance of a professional culture based on trust and mutual respect.

? 30% travel, including international travel, depending on business needs

海创药业是一家专注于癌症和代谢疾病的全球化创新药物企业，在美国、澳大利亚等地设有分支机构。公司依托氘代和PROTAC等技术平台，以“创良药·济天下”为使命，以为患者提供安全、有效、可负担的药物为重点，致力于研发和生产满足重大临床需求、具有全球权益的创新药物。
公司拥有“PROTAC靶向蛋白降解技术平台、氘代药物研发平台、靶向药物发现与验证平台及先导化合物优化筛选平台”4大核心技术平台。公司已申请 PCT和中国发明专利170余项，获得中国、美国、日本、欧洲等国家和地区专利授权50余项，现承担2项国家“重大新药创制”科技重大专项和多个省市级科研项目，拥有10项在研产品。公司拥有一支具有丰富药物研究、开发经验的管理团队，核心成员多来自世界500强知名药企，其中包括***人才专家2位、多位四川省人才专家。
公司现有产品管线中，用于治疗去势抵抗性前列腺癌的HC-1119正在中国和全球开展两项III期临床试验；用于治疗高尿酸血症和痛风的HP501正在中国开展II期临床试验。
公司已获得复星医药、广发信德、吉林敖东、深投控、泰格医药、国药中金、建银国际等众多知名机构的投资，总额约14亿元人民币。