Safety System Analyst, Pharmacovigilance - Oncopeptides
Pharmacovigilance / Safety · Sweden, Stockholm, Europe
We are looking for a Safety System Analyst for Oncopeptides. The company, which is listed on the Stockholm Stock Exchange, was founded in Sweden year 2000 and operates globally. Oncopeptides develops drugs for the treatment of cancer/hematology and is in a very exciting phase of development.
As Safety System Analyst you are responsible for supporting the analysis of safety data from Oncopeptides’ Pharmacovigilance (PV) Safety Database (SDB) primarily through the design and generation of reports for business use.
The role is responsible for maintaining the validated SDB and liaising with the application vendor. It also involves ensuring that change requests/enhancements to the system are deployed in accordance with company standards and aligned to requirements from business users within PV as well as cross-functional stakeholders.
- Design and implement reports and data queries from Oncopeptides’ SDB based on business requirements
- Support data analysis using tools like Microsoft Excel pivot tables
- Provide input to business processes on SDB functionality
- Review SDB release notes and provide risk assessment/impact analysis to business
- Monitor compliance of the SDB vendor to service level agreements (SLAs)
- Maintain users, product dictionary, MedDRA dictionary, study information and distribution rules in the SDB
- Support Computer System Validation (CSV) of SDB updates/upgrades including cross functional requirements gathering, Performance Qualification (PQ), and User Acceptance Testing (UAT)
- Provide technical support for data migration into/out of the Safety Database
- Support PV audit activities as required
Location: Europe, preferably Stockholm
- IT/IS/MIS degree combined with demonstrated experience of working with validated systems in Life Sciences
- At least 5 years of experience in Life Sciences, preferably Pharmacovigilance
- Prior experience in enhancements/change control of validated systems
- Experience with SQL/Business Intelligence tools (e.g., Tableau, Qlik Sense, Power BI)
- Experience with Veeva applications is a plus, especially Vault Safety
- Excellent written and verbal communication skills in English
Welcome to apply through: www.haegercarlsson.com
Questions are answered by Håkan Petersson +46(0)70-632 00 43, firstname.lastname@example.org
or Anna Wikman +46(0)73-539 33 87, email@example.com