Patient Safety Specialist, KSA

‎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 ex-ternalized, 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 clin-ical 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, Pro-curement, 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 Organiza-tion 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).

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.
Minimum requirements
Education: Health 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 local language
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
* Project management skills
* Computer skills
* ‎2 years as Patient Safety Specialist (preferred)
Division
SANDOZ
Business Unit
Commercial OPS SIR SZ
Country
Saudi Arabia
Work Location
Riyadh
Company/Legal Entity
SAUDI PHARMA DISTRIB SAU
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
Yes