Head of China Patient Safety
NovartisBeijingUpdate time: August 26,2019
Job Description
To oversee, coordinate, manage and support management of Patient Safety (PS) operational pro-cesses at Country Patient Safety Organization in ensuring compliance with Novartis global/local procedures, national and international regulations/ standards/guidelines for safety management of Novartis group/Alcon, Novartis and Sandoz marketed and investigational products (drugs and devices).
1. Single point of contact: If defined by local regulations act as the National/local Qualified Person for Pharmaco-device vigilance in the country (ies) and as the single point of contact with the Local Health Authority on a 24-hour basis concerning Pharmaco-device vigilance. 2. Acts as Country Head Novartis Patient Safety. Country Head Novartis Patient Safety may delegate the activities to a deputy (Country Head Novartis Patient Safety Deputy) but the ultimate responsibility remains with the Country Head Novartis Patient Safety. Delegation should be clearly documented. 3. Country PS Personnel: Select and recruit qualified Country PS associates and monitor their performance in accordance with Novartis processes. Periodically assess their workload in order to ensure that local resources are adequate to maintain quality and compliance of PS activities; if needed escalate need of resources to Countries & Regions. 4. Strategy: Create, implement and execute appropriate strategy for Patient Safety Organization at the Country level 5. Management of Safety Information: Manage collection, documentation, triage, translation (if applicable) processing in Novartis Safety Database, transferring to Central Processing sites (if applicable), follow-up, submission to local health authorities and archiving of all adverse events/special case scenarios for all Novartis products (drugs and devices) from pre and post-authorization (as applicable) phase according to the defined timelines and quality pa-rameters. 6. Reconciliation with other departments: Set up appropriate procedures with departments at Country Organization that may receive adverse event/special case scenario reports (e.g. Med-ical information, Quality Assurance, Sales force/Marketing, Legal, etc) and assure reconcilia-tion is performed. 7. Country Novartis PS Head/National QP training: Ensure current knowledge on pharmaco-device vigilance related matters through appropriate training on related Novartis proce-dures/relevant legislation as per pharmaco/device vigilance training curriculums and attend-ance at internal and external meetings. 8. Adverse event training in the Country Organization: Ensure that there is a process in place to guarantee that all Novartis CPO Associates, as well as local 3rd party, external vendors and local partners are adequately trained in general adverse event reporting and ensure that accurate and updated training materials are available for that purpose. ...
1. Single point of contact: If defined by local regulations act as the National/local Qualified Person for Pharmaco-device vigilance in the country (ies) and as the single point of contact with the Local Health Authority on a 24-hour basis concerning Pharmaco-device vigilance. 2. Acts as Country Head Novartis Patient Safety. Country Head Novartis Patient Safety may delegate the activities to a deputy (Country Head Novartis Patient Safety Deputy) but the ultimate responsibility remains with the Country Head Novartis Patient Safety. Delegation should be clearly documented. 3. Country PS Personnel: Select and recruit qualified Country PS associates and monitor their performance in accordance with Novartis processes. Periodically assess their workload in order to ensure that local resources are adequate to maintain quality and compliance of PS activities; if needed escalate need of resources to Countries & Regions. 4. Strategy: Create, implement and execute appropriate strategy for Patient Safety Organization at the Country level 5. Management of Safety Information: Manage collection, documentation, triage, translation (if applicable) processing in Novartis Safety Database, transferring to Central Processing sites (if applicable), follow-up, submission to local health authorities and archiving of all adverse events/special case scenarios for all Novartis products (drugs and devices) from pre and post-authorization (as applicable) phase according to the defined timelines and quality pa-rameters. 6. Reconciliation with other departments: Set up appropriate procedures with departments at Country Organization that may receive adverse event/special case scenario reports (e.g. Med-ical information, Quality Assurance, Sales force/Marketing, Legal, etc) and assure reconcilia-tion is performed. 7. Country Novartis PS Head/National QP training: Ensure current knowledge on pharmaco-device vigilance related matters through appropriate training on related Novartis proce-dures/relevant legislation as per pharmaco/device vigilance training curriculums and attend-ance at internal and external meetings. 8. Adverse event training in the Country Organization: Ensure that there is a process in place to guarantee that all Novartis CPO Associates, as well as local 3rd party, external vendors and local partners are adequately trained in general adverse event reporting and ensure that accurate and updated training materials are available for that purpose. ...
Minimum requirements
Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist). • Certified level of written and spoken English • Good working knowledge of local language • Knowledge of other languages desirable • At least 5-8 years experience in drug safety, pharma-covigilance area • Strategic and critical thinking • Ability to manage and develop people • Leadership and management skills incl. experience ex-cellent communications and negotiation skills, experi-ences in leading teams/personnel • High reliability • Good networking skills • Quality and focus oriented • Computer skill
927 million. That’s how many lives our products touched in 2017. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Join us and help us reimagine medicine.
927 million. That’s how many lives our products touched in 2017. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Join us and help us reimagine medicine.
Division
Global Drug Development
Business Unit
CMO & PATIENT SAFETY GDD
Country
China
Work Location
Beijing
Company/Legal Entity
CNIBR Co. Ltd.
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
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