Patient Safety Specialist

About The Role

This is a maternity cover position.

Location: Hybrid.

The purpose of the position is to support management of Patient Safety operational processes at Country Organization ensuring compliance with Novartis global and local procedures, national and international regulations/ standards/ guidelines for vigilance of both marketed and investigational products from Novartis Group.

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• 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 Program (POPs), 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.
• Manage reporting/submission/distribution of safety reports/updates/information to Local Health Authorities (LHA) and/or clinical operations in collaboration with other Country Organization Departments. Develop, update, and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
• 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 follow the Novartis vigilance requirements. Management and distribution of vigilance clauses to other departments to be included in local agreements if vital.
• Advice the owners of local contracts/ agreements with impact in the vigilance system, about the vigilance provisions to be included. 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.
• 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. Management and maintenance of all relevant local Patient Safety databases. Ensure that relevant local literature articles are screened as appropriate.
• 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 vigilance and ensure training of Country Organization associates. Ensure support to the internal audits, LHA inspections and implementation of the respective CAPA plan.
  
  

Commitment to Diversity & Inclusion:

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

Role Requirements

What you’ll bring to the role:

• Education: Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist), life science degree.
• Proficient Hebrew and English, both written and spoken.
• Knowledge of national and international regulations for pharmacovigilance.
• Knowledge of pharmacological and medical terminology.
• Good communication and interpersonal skills.
• Quality and results oriented.
• Digital literacy.
  
  

Why Novartis?

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network:

Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Division

Development

Business Unit

Patient Safety & Pharmacovigilance

Work Location

Tel Aviv

Company/Legal Entity

Novartis Israel

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Temporary

Shift Work

No

Early Talent

Yes