Apr 14, 2022

Job Description

-Monitors and audits the company’s drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against product labeling. Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May provide trending and safety signal detection and assessment. Supports all clinical trial activity and post marketing.
-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 -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Language: * Fluent in both written and spoken English • Fluent in both written and spoken local language Experience/Professional requirement: Knowledge of national and international regulations for pharmacovigilance • Knowledge of pharmacological and medical terminolo-gy. • Excellent communications, interpersonal and negotia-tion skills • Quality and focus oriented • Computer skills • Additional educational requirements as may be man-dated by national requirements

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

1- Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist) or equivalent education, training and
2- Fluent in both written and spoken English, Fluent in both written and spoken local language
3- Knowledge of national and international regulations for pharmacovigilance
4- Knowledge of pharmacological and medical terminology.
5- Excellent communications, interpersonal and negotiation skills
6- Quality and focus oriented
7- Computer skills
8- Additional educational requirements as may be mandatedby national requirements
Global Drug Development
Research & Development
Full Time
careers default image

Patient Safety Specialist

Apply to Job Access Job Account