Full-Time Safety Science Data Analyst

The Safety Science Data Analyst supports the Safety Science department’s mission of safeguarding patient health by generating actionable insights from safety data. This role will play a critical role in analyzing, visualizing, and reporting safety data to support signal detection, regulatory compliance, and informed safety-related decision-making. This position is essential to maintaining data accuracy, consistency, and traceability while enhancing the PV data infrastructure in collaboration with internal and external stakeholders.

The Safety Science Data Analyst works collaboratively with other members of the Safety Science Team, the Sobi Global Pharmacovigilance team, the Global PV Vendor System Manager, IT, Statistical and Medical Data Intelligence Center, and Quality, and other relevant functions across Sobi, to ensure that safety science activities are delivered to ethical and safety quality standards to ensure safety of patients, and compliance with GVP, GCP and worldwide regulatory requirements.

Key Responsibilities:

• Act as super user in the vendor’s safety database, collaborate with the Global PV Vendor System Manager and prepare data retrieval and visualization requests required for process-related or ad hoc activities.
• Evaluate and implement (as appropriate) fit for purpose data presentation e.g. for safety surveillance and signal evaluation activities, for aggregated reports or special scenarios including ad hoc requests from Health Authorities.
• Generate safety reports and dashboards using tools such as Excel, Power BI, and other data visualization platforms.
• Perform safety data queries and trend analyses from the safety database to identify patterns and anomalies.
• Support signal detection activities by providing data-driven insights and visualizations of case trends.
• Ensure the accuracy, consistency, and traceability of safety data to meet regulatory and organizational standards.
• Collaborate with IT teams, safety advisers, and the PV System Vendor Manager to enhance and optimize the data infrastructure.
• Translate complex data outputs into clear, actionable insights for non-technical stakeholders.
• Contribute to the continuous improvement of PV processes by identifying opportunities for automation and efficiency in data handling.
• Maintain compliance with global pharmacovigilance regulations and guidelines in all data-related activities.

Core Interactions:This position will work closely with Safety Advisers, Statistical and Medical Data Intelligence Center, IT teams, The PV System Vendor Manager, Regulatory Affairs and Quality Assurance teams.

Education/Learning Experience/Work Experience:
Required: Bachelor’s or Master’s degree in Data Science, Biostatistics, Computer Science, Life Sciences, or a related field. Knowledge of pharmacovigilance principles and safety databases (e.g., Argus, ARISg) 3-4 years of experience in data analysis, preferably within the pharmaceutical or healthcare industry. Hands-on experience with pharmacovigilance processes and case data structures is highly desirable.

Skills/Knowledge/Languages:
Required: Proficiency in data analysis tools such as Power BI, SQL, and Python/R. Strong understanding of pharmacovigilance processes, safety databases, and case data structures. Excellent data visualization skills with the ability to present complex data in a clear and concise manner.

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