北京招聘

The Position

We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. We are looking for an experienced (Senior) Drug Safety Physician to join our team.

Based in Shanghai, as a (Senior) Drug Safety Physician, you will be responsible for setting up safety strategy for related product. you will implement safety related evaluation and assessment as well as risk management plan to optimize benefit/risk profile of related product. You need to provide supports to the Function Head / line manager in all safety evaluation activities.

In this role, you will also be responsible for providing safety support to medical projects strategy and safety evaluation of Roche products in China, maintaining links and liaisons and timely communicating with external and internal (local and global) parties on safety matters. You will also own processes and ensures Roche product knowledge.

Your major responsibilities will include:

• Ensure 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.
• 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)
• Provide and accumulate TA-specific pharmacovigilance expertise, and applying this to various Business Units’ products - Provide safety input to Medical studies by reviewing safety section of protocol, CRF, ICF, CSR, SDEA and SMP.
• Provide safety input to License renewal, safety updates of local labels and solution of high impact cases. - Work with the relevant SRPL functions for responses to safety queries from China regulatory agency, media, patients, medical community and investigatorsSupports the Function Head/line manager in all safety evaluation activities.
• Work with SSL to contribute to medical projects including safety support to CTA/NDA applications and safety input to medical project teams, and to medical trials as a member of SMT.
• Provide safety support to medical activities, including :
  Safety input to Medical studies by reviewing safety section of protocol, CRF, ICF, CSR, SDEA and SMP
  Safety input to License renewal, safety updates of local labels and solution of high impact cases.
• Work with the relevant SRPL functions for responses to safety queries from China regulatory agency, media, patients, medical community and investigators.
• Write and keep updated local SOPs taking into account the global SOPs when delegated by the line manager.
• Ensure product and safety risk management knowledge.
• Perform proactive Safety Surveillance and Risk Management to effect product safety signal detection & evaluation, risk assessment and safety risk minimization.
• Act as a Point of Contact for Safety in the MBT Teams, ensuring a unified communication on safety matters.
• Provide and accumulate TA-specific pharmacovigilance expertise, and applying this to various Business Units’ products
  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)
• Ensure 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.
• Perform ad hoc special scholarly SS & RM activities, rapidly, to meet specific needs in the Business Units, such as Health Authority deliverables/emerging safety issue white papers/product Due Diligence Assessments.
• Engage in inspection readiness and support. Provision of data to project managers for metrics

Who you are

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

You have a master degree or above in Clinical Medicine. This is a position for professionals with 3-5 year as minimum in 3-5 in clinical and/or DS experience. Clinical experience or MNC pharmaceutical company experience in medical/PV related role is preferred.

Major competencies required:

• Good knowledge of assigned TA/disease area
• Good communication skill
• Business Acumen
• Education: Physician of outstanding performance
• Requirements on specific subject(s): preferably internal medicine or oncologist
• Language: Fluent written and spoken English and Chinese with communication skills
• Computer skill: Computer literacy
• Medical knowledge of Roche products
• Communication skills and teamwork
• Ability to drive the delivery of commitment in a matrix team

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.

The next step is yours. To apply today, click on the "Apply online" button below.

Who we are

At Roche, 85,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche China consists of Roche Pharmaceuticals and Roche Diagnostics, with more than 7,000 employees. While working to develop itself into Roche’s third global strategic centre, Roche China is also making sustained efforts to fulfill its long-term commitment to China.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry,

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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。

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