Overview
Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.
Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!
At Sobi, the work we do every day redefines the standards of care and transform the lives of people living with rare diseases.
As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always challenging the status quo.
We are committed to an inclusive, sustainable and flexible workplace that fosters growth and development.
Role Summary
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.
This role works 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 to ensure safety science activities meet ethical and safety quality standards and comply with GVP, GCP and worldwide regulatory requirements. It collaborates with the Global PV Vendor System Manager to provide performance oversight, support data requests and reports, and contribute to proper configuration and maintenance of the vendor safety database. It may lead IT system and data handling enhancements and contribute to vendor initiatives, piloting new technologies and integrating safety science advancements.
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 for process-related or ad hoc activities.
* Evaluate and implement fit-for-purpose data presentation for safety surveillance and signal evaluation, aggregated reports, or 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 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 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.
* Acts as back-up for the Global PV Vendor System Manager.
Core Interactions
* 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
* 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
* 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 judgment, proactive and decisive in risk assessment and issue escalation.
* Strong collaboration within PV function, leadership and the wider organisation.
* Has the expertise and courage to resolve or escalate issues as appropriate.
Personal Attributes
* 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.
* Delivery-focused with a solution-oriented mindset.
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 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. 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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