Safety Science Data Analyst

The Safety Science Data Analyst supports the Safety Science departments 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. It operates in collaboration with the Global PV Vendor System Manager to provide performance oversight facilitate the generation of specific Safety surveillance and ad hoc reports and contribute to the proper configuration and maintenance of the vendor safety database. This includes leading internal initiatives for IT system and data handling enhancements as well as contributing to vendor(s) initiatives. Other areas of focus include but are not limited to piloting and implementing new technologies integrating safety science advancements and innovation projects e.g. on smart data handling retrieval and visualization improvements.

Key Responsibilities

Including but not limited to the following:

• Act as super user in the vendors 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.
• Acts 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 the 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 35000 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:

• Bachelors or Masters 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.
• 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 collaborator within PV function leadership and the wider organisation
• 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 1800 employees in more than 30 countries and are 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 the areas of haematology immunology and specialty care. Sobis share is listed on Nasdaq Stockholm. More about Sobi at 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 cant 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.

Remote Work :

Yes

Employment Type :

Full-time