Patient Safety Associate-Pharmacist

1.Manage the collection, processing, documentation, reporting and follow up of all adverse

event re-ports for all Novartis products from Clinical Trials, Non interventional Studies, Patient

Oriented Pro-gram (POPs), Literature, Spontaneous Reports, and any other source of

information.

2.Transcribe, translate, and enter data from source documents into safety systems accurately

and consistently with focus quality and on timeliness. When case processing activities are

externalized, liaise with the respective External Service Providers to ensure Novartis

Procedures’ compliance.

3.Manage reporting/submission/distribution of safety reports/updates/information (e.g., SAE,

SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities (LHA) and/or

clinical operations in cooperation with other Country Organization Departments.

4.Develop, update, and implement local procedures to ensure compliance with Patient Safety

global procedures and national requirements.

5.Interact and collaborate with other departments (such as Medical Affairs, Marketing, Patient

Engagement, etc.) to ensure that any projects/ initiatives that potentially involve safety data

collection (POPs, DEAs, SM/SML, etc.) follow the Novartis vigilance requirements.

6.Management and distribution of vigilance clauses to other departments (such as Legal,

Procurement, etc.) to be included in local agreements if necessary

7.Advice the owners of local contracts/ agreements with impact in the vigilance system, about

the vigilance provisions to be included, as required per Novartis procedures and/or applicable

regulations.

8.Ensure compliance with the commitments disposed in the contracts/ agreements. Ensure the

applicable local contracts/ agreements are tracked in the respective Pharmacovigilance

Agreement Share Point. Ensure any significant departure from the standard vigilance templates

are communicated and endorsed by the global PS Alliance group.

9.Perform reconciliation with other departments (e.g, Medical Information, Quality Assurance,

and Third-party contractors, as applicable) for potential AEs resulting from medical inquiries,

quality related complaints and other sources.

10.Management and maintenance of all relevant local Patient Safety databases

11.Ensure that relevant local literature articles are screened as appropriate.

12.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.

13.Develop and update training materials for vigilance and ensure training of Country

Organization associates on relevant Patient Safety procedures for AE reporting, including field

force and third party contractors, as applicable.

14.Ensure support to the internal audits, LHA inspections and implementation of the respective

CAPA plan

Ideal Background

Education :

• Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist), life science degree or equivalent training and experience.

  Languages:

  • • Fluent in both written and spoken English
  • • Fluent in both written and spoken Malay Language.
  • • Fluent in both written and spoken Chinese Language will be added advantage

    Experience/Professional Requirement:

    • • Knowledge of national and international regulations for pharmacovigilance
    • • Knowledge of pharmacological and medical terminology
    • • Good communication and interpersonal skills
    • • Quality and results oriented
    • • Computer skill

Same benefit plan Hybrid working mode