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Set safety strategy and be Responsible for
the continued safety assessment, evaluation and risk management of DZ products
or product groups in various stages of clinical development
Responsible for continuous efficient
evaluation of adverse event and all other safety information in order to
predict and manage the safety profile of compounds in clinical development
through identifying the need for update to reference safety information and
drive proactive implementation of risk management initiatives in accordance
with regulatory requirements.
Provides consistent communication of safety topics across all regulatory safety
documents,.
Proactively evaluates the clinical
implications of safety data from clinical studies, literature and other
information sources in order to predict / establish the safety profile of
compounds in clinical development, including employing expert groups and
methodologies, modelling and simulation to manage the risk to patients.
Supports key contacts with opinion leaders,
as needed.
Role
& Responsibility主要职责
· Be responsible for the Clinical Safety monitoring and
management plan. Activities include, but are not limited to: definition of
identified and potential risks with high level mitigation and minimisation;
proposals for mitigation minimisation measures; safety go-no go criteria for
the clinical programme; response to regulatory safety queries and definition of
the risk component of the benefit/risk assessment.
· Reviews and endorses the core Patient Risk Management
Plan/Core Patient Risk Log.
· Provides expertise to the medical content of the safety
specification, pharmacovigilance plan and risk minimisation activities in the
core Patient Risk Management Plan, Core Patient Risk Log.
· Represents PS on cross-functional Clinical Teams and/or
Project Teams for developmental and/or marketed products.
· Provides medical input to ensuring that risk-minimisation
strategies are implemented appropriately in relevant documents such as product
reference safety information.
· Provides strategic and medical input to project specific
safety requirements. Reviews and provides technical input and approval for
investigator brochures, protocols, informed consents, final study reports and
external data monitoring committees as appropriate.
· Present safety information at clinical investigator and
commercial meetings.
· Provides medical input to regulatory supporting
documentation for labelling updates.
· Provides medical input into Identification and utilization
of appropriate sources of information and database searches to retrieve
relevant data for evaluation of signals.
· Provides medical input to deliver accurate and fit for
purpose safety evaluation documents with clear conclusions in response to
internal or regulatory authority requests for safety data.
Education,
Qualifications, Skills and Experience 任职要求
· Medical degree (eg MD, MBBS)
· At least 2 years of clinical
experience
· At least 5 years of Drug
Development/Patient Safety experience (the majority of which should be in
industry in Patient Safety) with clear evidence of delivery
· Drug Development Experience and Application of Disease and
TA knowledge
· Excellence in pharmacovigilance
· Patient Benefit risk assessment
The R&D (Research and Development) team of Dizal Pharma was AstraZeneca Asia and Emerging Market Research Center. As one of AstraZeneca’s first four R&D centers across the world, it dedicated to analyze the potential scientific mechanism of those most common diseases in Asia and fulfill the particular medical needs of Asian patients. It was one of the few R&D centers established by transnational pharmacy enterprises in China which had the ability to actually research, develop and produce micro-molecular new drugs, the ability to develop produce new drugs independently and completely, and the first-class medical platform in the world.
迪哲医药,于2017年10月独立运营,是一家研发驱动型生物医药企业,致力于全球创新药物(First-in-class/ Best-in-class)探索、研发以及商业化。
迪哲医药的前身为阿斯利康亚洲及新兴市场创新研发中心,设立于中国上海,是阿斯利康全球四个研发中心之一(另三个中心分别位于英国剑桥、瑞典哥德堡、美国盖瑟斯堡);是国际一流、高产出的创新药研发机构,拥有全球领先的转化医学和新药分子设计与筛选技术平台;在恶性肿瘤、自身免疫性疾病、肾病等重大疾病的新药研究方面积累了丰富经验。