北京招聘

Purpose:

Setting up safety strategy for related product. Implement safety related evaluation and assessment as well as risk management plan to optimize benefit/risk profile of related product. Providing safety support to medical strategy Timely communication with external and internal (local and global) parties on safety matters. Owns processes and ensures Roche product knowledge.

Primary Responsibilities include:

l Ensuring Consistency of Safety Risk Messaging for a particular product or class of products, across multiple indications/Business Units within the many safety reports and communications for that product. Providing suitable summaries of product risks to summary document authors where appropriate, for example providing medical content/B-R statements and overall risk messaging of the safety profile to Safety Authors.

l Act as a Point of Contact for Safety in the MBT Teams, ensuring a unified communication on safety matters. Perform frequent proactive Holistic Safety Review for products, across the span of relevant available safety data information. Reviews are incremental, cumulative and aggregate, to include the body of safety information available (e.g. clinical, epidemiology, spontaneous, literature & regulatory cases, other scientific data)

l Providing and accumulating TA-specific pharmacovigilance expertise, and applying this to various Business Units’ products

l Provide safety input to Medical studies by reviewing safety section of protocol, CRF, ICF, CSR, SDEA and SMP.

l Provide safety input to License renewal, safety updates of local labels and solution of high impact cases.

l Work with the relevant SRPL functions for responses to safety queries from China regulatory agency, media, patients, medical community and investigators

l Writes and keeps updated local SOPs taking into account the global SOPs when delegated by the line manager.

Qualification and Experience:

· Education/Qualifications教育程度/所获资格证书

o Master Degree in Clinical Medicine or above

o Clinical experience will be preferred

o MNC pharmaceutical company experience in medical/PV related role will be preferred

· Leadership Competencies领导者胜任力

o Ability to drive the delivery of commitment in a matrix team

·

· Job Required Competencies岗位所需胜任力

o Good knowledge of assigned TA/disease area

o Good communication skill

o Business Acumen

o

The statements made here are intended to describe the general nature and level of work being performed by people assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.

上海罗氏制药有限公司成立于1994年，是抗肿瘤、抗病毒、移植等关键领域的市场领导者。在大型跨国药企中，我们率先在中国建成了包括研究、开发、生产、营销等环节在内的完整的医药价值产业链。罗氏中国正向着成为罗氏全球第三个战略中心的目标迈进，以实际行动践行在中国长期发展的承诺。

我们始终以患者为中心，致力于帮助患者从根本上延长生命和改善生活质量。目前，罗氏在华拥有16个产品，覆盖8个治疗领域。我们与政府、医疗机构以及非政府组织等社会各界多方携手，共同探索创新的合作模式，通过一系列有影响力和可持续的举措惠及更多的中国患者。

更多罗氏中国信息，请登陆罗氏官网或访问罗氏招聘公众号。