Patient Safety Associate - Pharmacist

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

Major Accountabilities*

• 1.Manage the collection, processing, documentation, reporting and follow up of all adverse
• event reports 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 Thirdparty 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

hybrid working mode