Global Pharmacovigilance Digital Innovation & Technologies Manager

Purpose

Lead, promote, and accelerate the innovation of PV technologies. Serve as the primary point of contact for the Pharmacovigilance community regarding the introduction, validation, training, and maintenance of tools for PV document management (e.g., electronic safety document management systems, front-end solutions, robotic process automation). Support the daily maintenance activities related to digital tools used by Global Pharmacovigilance to keep them updated, thereby making a real impact on patient safety.

Main Responsibilities

• Contribute to designing tailor-made Pharmacovigilance IT solutions for the assigned area, ensuring they are kept up-to-date to achieve the company’s objectives and goals.
• Act as a facilitator during project management design for the implementation of new solutions in the assigned area or the upgrade of existing ones.
• Be responsible for Pharmacovigilance processes related to the assigned tools, including writing SOPs, WIs, and Internal Guidelines.
• Plan and supervise the implementation of IT solutions in the assigned Pharmacovigilance area.
• Serve as the point of contact for IT Service Providers and the Global Information and Communications Technology (GICT) department for the assigned systems.
• Assist PV Users (as the first point of contact) and PV Service Providers in the daily use of the assigned tools, evaluate their skills, and organize necessary training activities.
• Act as the key user for the assigned tools, keep the assigned sections (e.g., setting sections) updated and ensure that documents are stored following the procedures.
• Oversee local requirements that impact the assigned systems.
• Open deviations related to the activities under the role and contribute to investigations and the implementation of CAPA plans.
• Support change control management when Global Pharmacovigilance (GPV) assigned tools are impacted.
• Participate in activities related to acquisition and integration, including data migration for the assigned tools.
• Participate in audit and inspection activities.
• Provide data for the budget related to the assigned tools.
• Be responsible for providing information to be included in the Pharmacovigilance System Master File (PSMF) for the assigned tools.
• Be responsible for the qualification of spreadsheets used in GPV.    
• Contribute to assessing PV technology requirements (i.e., innovation), prioritizing new needs, and developing evolutionary strategies for Pharmacovigilance in collaboration with GPV, GICT, and key digital functional areas of the company. 
• Support and act as a backup for the Business Administrator for the Global Safety Database (Oracle Argus) and for integrated tools for data extraction and analysis (e.g., Business Object).  

Experience Required

Minimun 5 years of experience in Pharmacovigilance or Clinical Data Management.

Education

Degree in pharmacy, pharmaceutical chemistry, biological sciences, biomedical engineering, informatics or statistical sciences.

Languages

Fluent english

Technical Skills

• Excellent data analytics skills, document management in a GxP environment (e.g., PSMF), principles of Computer System Validation (CSV), technical and IT capabilities.
• In-depth knowledge of standard IT tools used in Pharma big data analytics.
• Integration of different systems.
• Ability to work in a dynamic, research-oriented group with several concurrent projects.
• Self-educated and up-to-date with all IT systems developments to ensure related implementation and innovation.
• Vault SafetyDocs from Veeva.

Soft Skills