摘要
About the Role
Key responsibilities:
- To support management of operational processes in ensuring compliance with Novartis global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance of Novartis marketed and investigational products -Manage collection, processing, documentation, reporting and follow-up of all adverse events (AE) reports for all Novartis products from clinical trials, post-marketing studies (PMS), Patient Oriented Programs (POP), registries and all Spontaneous Reports (SR).
- Transcribe, translate (where required) and enter data of all Serious Adverse Events (from Clinical Trials,) and all adverse events (from POPs, PMS, registries and all SRs) from source documents onto safety systems accurately and consistently with emphasis on timeliness and quality.
- Record and track receipts, submissions and distributions of documents like SAEs, SRs, Investigator Notifications etc in cooperation with other departments -Manage reporting/submission/distribution of safety reports/updates/information to Local Health Authorities and/or clinical operations in cooperation with other Departments.
- Work with other local/global PV associates to ensure accurate evaluation of safety data.
- Interact and exchange relevant safety information with LHA, PV associates, other functional groups and third party contractor, if applicable.
- Survey and monitor global/ regional/national (as applicable) pharmacovigilance regulations and provide update to global PVO organization.
- Develop, update and implement local procedures to ensure compliance with PVO global procedures and national requirements.
- Management and maintenance all relevant assigned PVO databases, if applicable.
- Develop and update training materials for pharmacovigilance -Ensure support for and close-out of audits, corrective action plan activities and Health Authority inspections.
- Provide timely, relevant information to trial coordinators, CRAs and other Novartis staff -Distribution of marketing samples (where applicable)
Essential requirements：
- Functional Breadth, collaborating across boundaries, operations management and execution.
- 2 years as Patient Safety Specialist (preferred)
Desirable requirements：
- Knowledge of national and international regulations for pharmacovigilance
- Knowledge of pharmacological and medical terminology
- Good communication and interpersonal skills Quality and results oriente Project management skills
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? http://www.novartis.com/about/strategy/people-and-culture
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
