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DSP specialist is operational oriented in AE collection, processing, reporting and follow-up of all adverse events (AE) reports for all MCPC products from various sources. To support DSP Manager in all activities as needed, ensure compliance with MCPC requirements and local regulations requirement. 1.Handle ICSR and any other interested safety cases from all source according to SOP and regulations. Contribute to China GVP and E2B submission implementation in China to make sure compliance with ICH. 2.Aggregate safety management and submission including develop aggregate report for local products and for product regulatory renewal. 3.Manage PV documentation。 4.Provide safety related training to internal and external stakeholder。 5. Liaise with key partners and 3rd party for safety information exchange and safety data reconciliation The Mundipharma story, spanning over six decades, is one that brings together a visionary approach and a pioneering spirit – and is best told through our patients, our employees and the communities in which we serve. Today we are an innovative company, with more than 3,500 employees across the Emerging Markets and a distribution network covering six continents. And this is just the beginning of our story in this region. As an organization, we are all about people. Innovation, continuous improvement, constant learning and sustainability are key to our business and our people are at the core of this. Mundipharma’s culture is dynamic, entrepreneurial, fun and high-performing. If you are someone who is focused and driven, looking to work at a place where you can take ownership, and make a real difference to improving the quality of patients’ lives, then this is the place for you.
Mundipharma
Beijing, China
Senior PV specialist.
SENIOR LEVEL