宜昌 [切换城市] 宜昌招聘宜昌生物/制药/医疗器械招聘宜昌临床协调员招聘

Drug Safety & Medical Advisor

美纳里尼(中国)投资有限公司

  • 公司规模:10000人以上
  • 公司性质:外资(欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2016-09-20
  • 工作地点:上海-普陀区
  • 招聘人数:1人
  • 工作经验:3-4年经验
  • 学历要求:硕士
  • 语言要求:英语 精通
  • 职位月薪:20-30万/年
  • 职位类别:临床协调员  

职位描述

职位描述:
Essential Responsibilities

1. AE Processing
1) To collect, process and follow up all local adverse events(AEs) from different sources
2) To report the AEs to the HA according to the Chinese regulation within the required timeframe and answer any subsequent questions in collaboration with Regional Director – Pharmacovigilance in liaison with the GPV(Global pharmacovigilance)
3) To log in cases into the local tracking system and transmit all reports to the IDSCU within the required timeframe; answer the queries of the IDSCU in a timely manner
4) To answer the safety questions from the Health Care Professionals with the support of Regional Director – Pharmacovigilance
5) To archive all source documentation in accordance with standard operating procedures
6) To maintain a record of PhV source documents and keep them available on request by the HA
2. Studies Activities
1) To review protocols for clinical trials sponsored by the country, in order to ensure compliance with the PhV requirements
2) To submit Serious Adverse Event(SAE, unexpected events to HA according to the national regulations
3. Provide timely and high-quality medical input to business teams and achieve the following responsibilities:
1) Assist in business decision-making
? Provide medical inputs in new product planning and product strategic planning
? Sustain Medical expertise for the defined therapeutic areas, by self-studying and internal/external academic training
? Provide timely medical input in product crisis management
2) Participate in product commercial activity (Marketing, Sales)
? Provide medical input to product team in product positioning and differentiation
? Develop clinical research proposal for the defined therapeutic areas
? Review promotional materials and promotional activities
? Provide medical inputs in developing training program on disease knowledge in the defined therapeutic areas to sales training group
3) KOL management
? Regular communication with KOLs to share most updated medical information and maintain the relationship in the defined therapeutic areas
? Review the Investigator Initiated Study Program.
4) Lecture delivery and product training
? Regular lecture, to share most updated clinical trial data, interpreter treatment guideline and provide summary of product efficacy and safety profile.
? Product training to internal and external customers,
4. Provide timely and high-quality medical input to medical teams and achieve the following responsibilities:
1) Medical information Support
? Provide medical input to medical information team in setting up medical query responding systems
? Liaise between business team and medical information team, to ensure timely delivery of medical information
? Proactively provide the latest medical information to internal and external customers on regular basis
? Discuss research concept with interested investigator, and communicated the nature and requirement of Menarini IIT. Facilitate submission of investigator initiated pre-clinical and clinical proposals, and act as a Liaison between Menarini and IIT researcher.
2) Regulatory activities
? Timely review and approve local product labeling for products
? Review and approval of phase IV clinical trial application based on Market needs
? Provide medical input in feasibility studies for global trials

Required requisites

? Medical Background in the defined therapeutic area, Master or Doctor Degree in therapeutic area is preferred.
? At least 2 years clinical practice.
? At least 2 years medical affairs experience in multinational pharmaceutical companies. Familiar with the relevant regulations, with experience in PhV
? Proficiency in both oral and written English.
? Good communication skill, ability to liaise with different function involved: MA, QA, RA and MKT & sales team, etc.Good capability of strategic and analytical thinking. Proactive planning and result oriented.
? Broad medical knowledge and good understanding about pharmaceutical business.
? Good interpersonal communication skills.

职能类别: 临床协调员

关键字: 医学顾问

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公司介绍

Menarini集团总部位于意大利佛罗伦萨,是一家集研发、生产为一体的全球著名制药公司。它拥有:
• 128年的悠久历史,业务覆盖全球100多个国家
• 2012 年营业额达40亿欧元,全球超过17,000名员工
• 意大利***的跨国医药集团
• 欧洲排名前11位的制药公司 (5296家制药公司)
• 世界排名38位(17771家制药公司—数据来源IMS)

Core Values 我们的核心价值:
·Ambition 锐意进取 — 站在医药行业的最前沿是我们的目标
·Integrity 诚实守信 — 言必行,行必果
·Sense of Urgency紧迫意识 — 积极主动,志在必得
·Customer Focus 客户至上 — 满足客户需求,超越客户期望

Core Competencies 我们的核心能力:
·Entrepreneurial & Innovative 创业精神和创新意识
·Execution Excellence 卓越的执行力
·Environment Acumen 环境敏锐性
·Enriching Self & others 自我提升和丰富他人
  
目前我们的产品主要集中在整形科,产科、心血管科、眼科、皮肤科等领域。自2013年开始,我们已陆续引进消费者健康、外用止痛等领域产品并将继续引进高渗鼻喷雾剂、中枢镇痛、脂溢性皮炎、放射性皮炎、口服抗组胺药物等系列自有品牌的产品,逐步实现“成为亚洲的全球制药巨头”的远大目标。
2011年11月11日,英维达集团被Menarini集团成功并购,我们成为了Menarini制药集团在亚太区的事业中心。此次并购为我们今后的发展奠定了新的方向和坚实的基础,2013年10月29日,美纳里尼(中国)投资有限公司正式成立。美纳里尼中国作为此次并购的全球重点策略性市场,将在总部提供临床学术支持的基础上陆续上市自主研发产品,走进全面发展的新纪元。
公司秉承以人为本的理念,注重人员的培养和发展,在公司快速发展的过程中,诚邀有强烈发展意愿和富有挑战精神的人士加入,与我们携手共同创造美纳里尼中国的美好明天。

详情请访问公司官网:***********************/

联系方式

  • 公司地址:上海市普陀区 (邮编:200060)