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Jobs in Malaysia   »   Jobs in Petaling Jaya, Selangor   »   Education / Training jobs   »   Safety Training Officer

Safety Training Officer

Petaling Jaya, Selangor
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Job Description

About GDD

Novartis' Global Drug Development (GDD) organization oversees drug development activities for our Innovative Medicines Division and the biosimilars portfolio of our Sandoz Division. Development of small-molecule generics for our Sandoz Division is not included in GDD. GDD works collaboratively with the Novartis Institutes for Biomedical Research (NIBR), Innovative Medicines and Sandoz to execute our overall pipeline strategy and takes an enterprise approach to pipeline portfolio management.

The GDD organization includes centralized global functions such as Regulatory Affairs and Global Development Operations, as well as Global Development units aligned with our business franchises. GDD includes approximately 11,000 full-time equivalent associates worldwide.

Under our Global Drug Development unit, the focus of our development program is to determine and then establish the safety and efficacy of a potential new medicine in humans.

Novartis GDD offers an extraordinary work experience with a real opportunity to develop in a highly fast-paced technology-driven environment where collaboration and innovation are at the heart of who we are and what we do.

Position Purpose

To support management of Patient Safety operational processes at Country Organization in ensuring compliance with Novartis global/local procedures, national and international regulations/ standards/guidelines for pharmacovigilance of Novartis group marketed and investigational products.

Key Responsibilities

  • Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all Novartis products from clinical trials, non-interventional studies, Patient Oriented Programs, literature, Spontaneous Reports, etc. Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality.
  • Manage reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities and/or clinical operations in cooperation with other Country Organization Departments.
  • Work with other local/global Patient Safety associates to ensure accurate evaluation of safety data.
  • Interact and exchange relevant safety information with LHA, Patient Safety associates, other functional groups and third party contractor, if applicable.
  • Survey and monitor national pharmacovigilance regulations and provide update to global Patient Safety organization.
  • Develop, update and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
  • Input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information.
  • Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance and third party contractor, if applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources.
  • Management and maintenance of all relevant Patient Safety databases.
  • Prepare and submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to LHA, development and implementation of corrective action(s) as needed.
  • Develop and update training materials for pharmacovigilance and ensure training of Country Organization associates on relevant Patient Safety procedures for AE reporting, including field force and third party contractor, if applicable.
  • Ensure support for and close-out of audits, corrective action plan, investigation and Health Authority inspections.
  • Ensure training and oversight of staff, as applicable.
  • Manage and maintain efficient Patient Safety filing and archive system.
Minimum requirements

  • Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist).
  • Fluent in both written and spoken English.
  • Knowledge of national and international regulations for pharmacovigilance.
  • Knowledge of pharmacological and medical terminology.
  • Excellent communications, interpersonal and negotiation skills.
  • Quality and focus oriented.
  • Computer savvy.
Functional Area

Research & Development

Division

Global Drug Development

Business Unit

CMO & PATIENT SAFETY GDD

Employment Type

Regular
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