职责描述：

• Contribute to the oversight of the assigned cross sector product portfolio, and link with local management and key stakeholders;
• Contribute to ensuring compliance with all MS regulatory reporting requirements in a timely manner e.g RMPs, aggregate reports;
• Support the business with MS support for local organized data collection programs, post marketing programs, RWE studies etc.;
• Escalate compliance issues in a timely manner to Line Manager and China Cross Sector Safety Lead to ensure appropriate mitigation is implemented;
• Identify periods of high MS workload and escalate to line manager to ensure MS resource is allocated appropriately to address them;
• Support process improvements to optimize MS activities;
• Work collaboratively with local MS colleagues to ensure consistency of approach across groups;
• Build and maintain effective business relationships across the LOC;
• Support the MS Manager to provide high quality and consistent input to development of local safety initiatives and programs;
• Contribute towards an environment of continuous improvement within the MS team;

- Assist with SUSAR assessment - from a compliance and monitoring perspective – looking for potential signals, risk control plan development (environmental impact on patient safety – site suitability and selection);

• Assist with Signal detection – ensure LOC complies with any local HA signal-detection requirements, collaborate with regional and global colleagues to signal detection activities and communications;
• Intensive monitoring programs including Compassionate Use Program, Patient Access Program, Registries, Post-Marketing Studies – involvement with key stakeholders to ensure the programs meet local, regional or global requirements from a compliance and strategic safety perspective;
• Monitor any MS service providers to ensure PV and MS obligations are being fulfilled;
• Collaborate with Regulatory Affairs to forward any safety-related inquiry or relevant communication from the local RA to the appropriate global and regional groups as appropriate. Collaborate with appropriate departments to identify the resources and expertise needed to address the question. This may include local, regional and/or global expertise;
• Support MS Manager in collaborations with compound teams/cross-functional teams in MS relevant areas of product lifecycle management including pre-launch activities, dossier preparation, risk minimisation activity (planning, implementation, evaluation strategy), intensive monitoring programs;
• Support MS Manager in collaborations with Medical Affairs for the review and approval of safety aspects of local study protocols to ensure appropriate safety reporting to GMS or appropriate case management center and Health Authority, as required;
• Provide MS related input and participate in projects led by the regional and global MS team;
• Contribute towards the development of an appropriate system of Risk Management in order to assure appropriate oversight for products within its responsibility;
• Assist with the development of a China specific RMP as required according to local requirements, if applicable;
• Collaborate with Medical Affairs and Regulatory Affairs team to ensure that RMP activities are completed on a timely manner;
• Ensure implementation and tracking of RMP activities are in place including documentation of completed activities;
• Assist in the review all risk management plans and PSURs to obtain information on the risk/benefit profile of products;
• Provide balanced, accurate and timely medical information in response to requests from internal and external customers;
• Report spontaneous Adverse Events to Local Safety Officer or designee;
• Report Product Complaints to Business Quality;
• Maintain Medical Information responses with up-to-date and relevant information for assigned products or therapeutic area;
• Generate monthly /annual report regarding MI inquiries;
• Manage outsourced Medical Information (MI) center;
• Set up and maintain promotional material review process;
• Review promotional materials in compliance with Corporate and regulatory requirements;
• Advise sales and marketing with scientific and professional advice regarding promotional materials and promotion strategy;
• Pre-consulting abut promotional materials;
• Advise internal customers on promotional materials or medical review guideline;
• Training stakeholders regarding Medical review SOP and local regulations;
• Keep the medical compliance for lowing the company’s risk;
• Provide scientific support through literature updates, bulletins and other topic of interest to internal customers;
• Support of cross-functional Business Unit activities, as required.

任职要求：

• Medical, pharmacy or life-sciences degree (or equivalent);
• 3-5 years of experience in PV/Medical safety/Medical Information is essential; experience working in the pharmaceutical industry is strongly preferred;
• Fluency in written and oral English and Mandarin;
• Knowledge in Medical/Health Sciences required;
• Knowledge of local/global legal requirements;
• Knowledge about local business models and local legal requirements;
• Knowledge of global and local Standard Operating Procedures (SOPs), and GMS database systems;

- Demonstrable insight to the implementation PV regulatory requirements for medicinals, devices and cosmetics with knowledge of Global aspects of drug safety, including International AE reporting requirements and relevant country- specific variations;

• Familiarity of general industry principles of drug development;
• Awareness of aspects of the business and strategic company goals.

上班地址：上海