Job Description

MAIN ACCOUNTABILITIES AND DUTIES

• Serialization Alert Management Specialist works in the Serialization technology ecosystem within the Information Technology organization, as part of Zentiva Serialization and related Track & Trace activities.
• Manage alert management to track, investigate and solve incoming alerts generated on the market and coming from European Medicines Verification Organization.
• Is a Technical System Owner (TSO) for the Zentiva Alert Management solution as well as the key user of the solution.
• Responsible for alert tickets processing, including evaluation, assignment to internal teams and tracking of execution when needed.
• Responsible for final resolution of the incoming alerts.
• Responsible for alert resolution reporting to National Authorities or National Organizations.
• Daily communication with National Organizations.
• Proactive participation and contribution on meetings and projects managed by European Organizations.
• Detailed monitoring of trends in the field of Serialization, Track & Trace and related alert management.
• Identify opportunities for process and application enhancements and drive the execution of the approved one.
• Close cooperation with suppliers on application evolutions design and execution.
• Employ statistical techniques to examine incoming data.
• Develop and maintain customized reports and dashboards within given application.
• Ensure data accuracy and integrity in all reports.
• Create and manage data visualizations to present complex information clearly
• The employee will perform any other task as needed and indicated by the Manager within the Zentiva serialization activities.

OTHER RESPONSIBILITIES

QUALITY

• Adheres to the principles of pharmaceutical Good Practices (GxP) in the extent related to the performed activity.

HSE

• Adheres to the principles communicated within the ESMS Policy of Zentiva detailed in the internal rules of the Company for the purpose of observing the rules of the Health & Safety at Work and the Environmental & Safety Management System.

PHARMACOVIGILANCE

• All employees are obliged to report any suspicion to adverse events of medicinal products, any adverse events concerning use of a medical device and any other safety information about medicinal products or medical devices in line with relevant internal regulations

COMPLIANCE*

*) country specific

• The employee will comply with all internal rules of the Company, mainly with the Working Order of the Company and all other internal rules specifying the provisions of the Working Order. The employee will make her/himself acquainted with the Code of Ethics (Zentiva “Code of Common Senses”) and will comply with the principles stated therein and in all related policies and other internal documents.

MANAGERIAL POSITIONS REQUIRE:

• Creates, manages and evaluates the risk register and environmental aspects. Informs and trains employees and verifies their knowledge of the above.

COMMUNICATIONS & WORKING RELATIONSHIPS*

*) not a mandatory field

Internal

• Serialization Team, Manufacturing (plants), IT

External

• Serialization solution/project providers
• National and European medicine verification organizations
• National Health Authorities

Deputy*

• NA

REQUIRED QUALIFICATIONS, EXPERIENCE & SKILLS

• Minimum 3 years of experience in supply chain, information technology, pharma industry or data analysis. Previous experience in serialization operations will be considered an asset.
• Experience in supporting multiple business functions (Supply Chain, IT, Quality etc.)
• Action oriented and results driven with an ability to drive new and innovative solutions in alignment to the organizations / functions strategy.
• Proactivity in all aspects of the operation
• Ability to clearly and succinctly communicate with key business partners is essential, including senior executives
• Excellent written, visual, and oral communication skills are essential with proficiency in Microsoft Office suite
• Experience working with teams in different geographical locations on a daily basis
• International experience is a plus
• GMP and GDP experience is a plus
• Ability to work under pressure and meet tight deadlines.
• A deep understanding of the industry and business operations is a plus.
• Strong analytical and problem-solving skills.
• Attention to detail and a high level of accuracy.
• Ability to work independently and as part of a team.
• Strong organizational and time management skills.
• Strong understanding of data privacy and security principles.
• Experience with cloud-based data solutions is a plus.
• English - B2 level (Upper Intermediate – oral x written)