Safety Database Specialist
Milano, IT
Job Purpose
Support Pharmacovigilance Business Administrator (BA) for the maintenance and implementation of all the systems and tools used for the management of the Pharmacovigilance activities.
Key Responsibilities
Responsible for the activities related to the implementation and maintenance of the systems (e.g., Oracle Argus, Veeva Vault) and tools (e.g., Group SharePoint) used for the management of the Pharmacovigilance activities. These include:
• Databases/tools configuration based on new company requirements.
• System updates to be always in compliance with current legislation.
• Users support and training for the use of the PV systems; interaction with the concerned internal departments, Affiliates and Providers.
• Support the validation activities (such as documents preparation, validation tests executions, maintenance of documentation as required by SOPs/WIs and standards).
• Preparation of the relevant SOPs and WIs.
• New system functionalities implementation and related functional tests execution (for instance due to internal process efficiency).
Required Education
A scientific/IT degree with, at least, basic knowledge of pharmacovigilance requirements/obligations are required.
Required Skills and Experience
At least 1-2 years’ experience in similar role in a pharmaceutical company. Familiar to CSV/Data Integrity knowledge.
Technical Competencies
Must have: strong knowledge of Pharmacovigilance Safety Databases
Nice to have: good knowledge Oracle Argus;
Familiarity with Qdocs or comparable systems (such as Veeva).
Required Behaviours and Competencies
Able to work in team and have problem-solving skills; timely management and meeting deadlines.
Required Languages
Good knowledge (written and oral) of English is required. Further knowledge of languages is well recognized.