Patient Safety Specialist

Job title: Patient Safety Specialist

Company: Novartis

Job description: Job Description

Sandoz is commited to helping millions of patients access biologic medicines sustainably in areas including oncology. With a strong portfolio of eight marketed biosimilars and a further 15+ in various stages of development, Sandoz has an unparalleled heritage and extensive expertise in the development, manufacturing and delivery of biosimilar medicines to patients and healthcare community.

Would you like to work for a Global Generics and Biosimilar company and contribute to our mission to extend and improve people’s lives? Join Sandoz!

Your responsibilities include, but are not limited to:

1.Manage the collection, processing, documentation, reporting and follow-up of all adverse event reports for all Sandoz products from Clinical Trials, Non-interventional Studies, Patient Orient-ed Program (POPs)s, Literature, Spontaneous Reports, and any other source of information. 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 Sandoz procedures’ compliance.

2.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.

3.Develop, update, and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.

4.Interact and collaborate with other departments (such as Medical Affairs, Marketing, Patient Engagement, etc.) to ensure that any projects/ initiatives involving safety data collection (POPs, DEAs, SM/SML, etc.) follow the Sandoz vigilance requirements.

5.Management and distribution of vigilance clauses to other departments (such as Legal, Procurement, etc.) to be included in local agreements if necessary.

6.Advice the owners of local contracts/ agreements with impact in the vigilance system, about the vigilance provisions to be included, as required per Sandoz procedures and/or applicable regulations.

7.Ensure compliance with the commitments disposed in the contracts/ agreements. Ensure the applicable local contracts/ agreements are tracked in the respective Pharmacovigilance Agreement SharePoint. Ensure any significant departure from the standard vigilance templates are communicated and endorsed by the global PS Alliance group.

8.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.

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

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

11.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.

12.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.

13.Ensure support to the internal audits, LHA inspections and implementation of the respective CAPA plan.

14.Other agreed tasks assigned by manager (To be detailed here).

Minimum requirements

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


  • Fluent in both written and spoken English
  • Fluent in both written and spoken local language

Functional Area

Research & Development



Business Unit

Commercial OPS SIR SZ

Employment Type


Commitment to Diversity & Inclusion:

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

Shift Work


Early Talent


Expected salary:

Location: Dubai

Job date: Thu, 09 Feb 2023 00:23:49 GMT

Apply for the job now!


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