The purpose of Idorsia is to discover, develop and commercialize innovative medicines to help more patients. To achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core.
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The **Business Analyst - Drug Safety Systems** supports and enhances applications used by the Global Drug Safety organization. Working closely with business stakeholders, the role translates business needs into effective system solutions, supports complex reporting and analytics, and ensures systems operate in a compliant and efficient manner.
This position is ideal for an early-career professional with a strong technical aptitude and background in information systems, data analytics, or related technologies, who is interested in developing expertise in Pharmacovigilance processes, regulated systems, and business analysis within the pharmaceutical industry.
# Key Responsibilities #
* Support the administration, configuration, and maintenance of Drug Safety Systems and related applications.
* Partner with business stakeholders to understand requirements, identify improvement opportunities, and deliver effective system solutions.
* Support reporting and analytics activities, including standard and ad hoc reports related to medical surveillance, compliance, and operational metrics.
* Assist with implementation of new functionalities, system enhancements, and release activities.
* Perform system validation activities, including testing, documentation, and user communication.
* Act as a primary contact for system issues, coordinating resolution with IT teams and external vendors.
* Provide end-user support, troubleshooting, and training.
* Create and maintain system documentation, procedures (SOPs, WISs), and training materials.
* Ensure compliance with Computer System Validation (CSV) requirements, corporate policies, and applicable regulations.
* Continuously develop expertise in Pharmacovigilance/Drug Safety processes, systems, and industry best practices.
# Candidate-s Requirements #
**Education & Experience**
* Bachelor's degree in Life Sciences, Information Systems, Computer Science, or a related discipline.
* Ideally 2-3 years of experience in the pharmaceutical or life sciences industry, preferably within Pharmacovigilance, Clinical Development, or other regulated GxP environments. Experience gained through internships, trainee programs, or graduate roles is also valued.
* Interest in Drug Safety and Pharmacovigilance processes, with a willingness to develop expertise in related systems and business processes.
**Technical Skills**
* Experience with data analysis, reporting, data visualization, and dashboarding tools; experience with Oracle Business Intelligence is an advantage.
* Knowledge of database concepts, data warehousing, and data management principles. Experience with SQL and PL/SQL is desirable.
* Experience with regulated business applications, such as Drug Safety Systems, Quality Management Systems, or Document Management Systems, is an advantage.
**Compliance & Quality**
* Understanding of Computer System Validation (CSV) principles and regulated environments; knowledge of 21 CFR Part 11 is an advantage.
* Exposure to GxP environments and familiarity with GAMP 5 and ITIL concepts is beneficial.
* Strong quality mindset with attention to detail and a commitment to maintaining accurate documentation and compliant processes.
**Personal Skills**
* Strong analytical and problem-solving skills with the ability to translate business needs into practical solutions.
* Effective communication and stakeholder management skills.
* Self-motivated, proactive, and eager to learn in a dynamic environment.
* Collaborative team player who contributes to a positive and respectful working culture.
* Fluent in English both written and spoken; knowledge of French or German is an advantage.
# **What we offer:** #
* **Purpose-driven work:** Contribute to systems that support patient safety and help ensure the safe use of innovative medicines worldwide.
* **Meaningful impact:** Join a collaborative team where your ideas and technical expertise directly contribute to improving business processes and regulated systems.
* **Modern ways of working:** Collaborate with experienced professionals in an environment that values teamwork, innovation, and continuous improvement.
**Work Location:** Allschwil, Switzerland
**Business Area:** Global Information Services
**Schedule:** Fulltime
**Job Type:** Permanent
**Job ID**: 4829
***At Idorsia, we harness the power of difference, authenticity, and inclusion to achieve business success.
We encourage all potential candidates with diverse backgrounds of race, color, religion, sexual orientation, gender identity, age, national origin, and disability to submit their job applications. All applicants will receive consideration.
We are committed to fostering respect, fairness, and equal opportunities for all job applicants and our employees.***
*Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.*
*Idorsia Pharmaceuticals Ltd ("Idorsia") is committed to a fair and transparent application process. In order to avoid any conflict of interest in line with Idorsia Code of Business Conduct, which would undermine such a commitment, the applicants must disclose any personal, financial, or other outside interests interfering with the interests of Idorsia. Further, the applicant is obliged to disclose any and all relationships with close or affiliated persons, who are employees of Idorsia or are collaborating with Idorsia in any other contractual relationship. *
*Please note Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates, or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.*
