Jun 15, 2022

Job Description

Job Purpose

As a Patient Safety Specialist in Global Drug Development (GDD), you will support management of Patient Safety operational processes at Country Organization in ensuring compliance with Novartis global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance of Novartis group, marketed and investigational products.

Key Responsibilities include but not limited to:
• Manage collection, processing, documentation, reporting and follow-up of all adverse event (AE) reports from clinical trials, non-interventional studies, Patient Oriented Programs, social media and other digital assets, literature, spontaneous reports, etc.
• Work with other local/global Patient Safety associates to ensure accurate evaluation of safety data.
• Management and maintenance of all relevant Patient Safety databases.
• Input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of AE information.
• Develop and update training materials for pharmacovigilance and ensure training of Country Organization associates on relevant Patient Safety procedures for AE reporting, including field force, partners and vendors.
• Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance and third party contractors) for potential AE resulting from medical inquiries, quality related complaints and other sources.

Diversity & Inclusion / EEO

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

Minimum Requirements

What you will bring to the role:
• Degree in scientific or healthcare discipline or equivalent education, training and experience
• Minimum of 1 year pharmaceutical industry experience particularly relating to pharmacovigilance or other relevant experience
• Fluent in both written and spoken English and Greek
• Knowledge of national and international regulations for pharmacovigilance
• Knowledge of pharmacological and medical terminology
• Excellent communication, interpersonal and negotiation skills
• Quality and focus oriented
• Computer savvy
Global Drug Development
Research & Development
Part Time
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Patient Safety Specialist (part time 60%)

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