347576BR
Jul 13, 2022
Greece

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

Job 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
CMO & PATIENT SAFETY GDD
Greece
Athens
Research & Development
Full Time
Temporary
No
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347576BR

Patient Safety Specialist (Temporary 12 months)

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