Overview Job Description
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 analyzes, visualizes, and reports safety data to support signal detection, regulatory compliance, and informed safety-related decision-making. It maintains 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 the Safety Science Team, the Sobi Global Pharmacovigilance team, the Global PV Vendor System Manager, IT, Statistical and Medical Data Intelligence Center, Quality, and other relevant functions across Sobi, to ensure that safety science activities are delivered to ethical and safety quality standards and in compliance with GVP, GCP and worldwide regulatory requirements. It collaborates with the Global PV Vendor System Manager to provide performance oversight, generate specific Safety surveillance and ad hoc reports, and contribute to the proper configuration and maintenance of the vendor safety database. This includes leading internal IT system and data handling enhancements and contributing to vendor initiatives. Areas of focus include piloting and implementing new technologies, integrating safety science advancements and innovation projects on smart data handling, retrieval and visualization improvements.
Responsibilities Including, but not limited to the following:
Act as a super user in the vendor’s safety database, collaborate with the Global PV Vendor System Manager, and prepare data retrieval and visualization requests for process-related or ad hoc activities.
Evaluate and implement fit-for-purpose data presentation for safety surveillance and signal evaluation activities, 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 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.
Act as back-up for the Global PV Vendor System Manager.
Core Interactions This position will work closely with:
Safety Advisers to provide data insights for case evaluations and signal detection.
Statistical and Medical Data Intelligence Center to ensure high-quality clinical outputs and visualizations.
IT teams to ensure robustness and scalability of PV data systems.
The PV System Vendor Manager to address system-related issues and implement enhancements.
Regulatory Affairs and Quality Assurance teams to ensure alignment with compliance requirements.
Size & Dimension of the Role Responsible for generating and maintaining safety reports and dashboards for ~35,000 cases annually.
Authority to design and review data visualizations and reports for internal and external stakeholders.
Expected to handle multiple projects simultaneously with minimal supervision, ensuring timely delivery of high-quality outputs.
Qualifications 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 clearly.
Knowledge of MedDRA coding and the ability to assess the impact of MedDRA updates on safety data and reporting.
Familiarity with safety database updates and their implications for PV operations.
Strong analytical and problem-solving skills with attention to detail.
Ability to communicate effectively with both technical and non-technical stakeholders.
Fluency in English (written and spoken); additional language skills are a plus.
Ability to work effectively to fulfill ambitious goals.
Sound and balanced judgment skills; able to assess and handle risks; self-confident, proactive and decisive.
Strong collaboration within PV function, leadership, and the wider organization.
Has the expertise, determination and courage to resolve or escalate issues as appropriate.
Personal Attributes Required :
Highly organized with the ability to manage multiple priorities and deadlines.
Strong collaboration and interpersonal skills to work effectively in cross-functional teams.
Proactive and self-motivated with a commitment to continuous learning and improvement.
Adaptable to a fast-paced, dynamic work environment.
Proven delivery focus and solution builder.
Additional Information How to apply
We have an ongoing selection process in this recruitment and ask you to send your application as soon as possible. Click apply and include your resume in English.
Why Join Us? Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:
Emphasis on work / life balance
Collaborative and team-oriented environment
Opportunities for professional growth
Diversity and Inclusion
Competitive compensation for your work
Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
Sobi is a global company with over 1,800 employees in more than 30 countries and is committed to the societies where we operate. We are a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases, providing reliable access to innovative medicines in haematology, immunology, and specialty care. Sobi’s share is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.
We know our employees are our most valuable asset and our culture conveys that. We offer a competitive benefits package to support the health and happiness of our staff.
Sobi Culture At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them.
As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.
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