Interim Global PV ICSR Manager in Stockholm

This is a consulting assignment where you will be employed as a consultant by Jurek Talents or have the opportunity to enter as a subcontractor. The assignment is expected to last for ap-proximately 4-6 months, starting in June, with a possible extension. Our client is a leading international biopharmaceutical company dedicated to transforming the lives of people with rare diseases. They provide innovative treatments in various therapeutic areas, focusing on improving patient outcomes.Position OverviewWe are seeking a dedicated and experienced Global PV ICSR Manager to join the team. The Global PV ICSR Manager will be responsible for managing single case safety reports across our company and our case processing vendor functions. This role is cru-cial in ensuring that safety case reports are processed and assessed to high standards and with-in required timelines, ensuring global reporting compliance and contributing to signal assess-ment.Key Responsibilities :

• Manage the mailboxes owned by the Global PV Systems and Operations team.
• Provide guidance on ICSR-management investigations and issues raised by the case processing vendor.
• Oversee day-to-day case processing activities performed in-house.
• Collaborate with the Global PV Case Management Lead and Global PV Vendor Inter-face Manager to drive process improvements.
• Ensure appropriate certification of case processing vendor staff, including test cases for database access.
• Conduct QC for out-of-process ICSRs for our products and partner products, provid-ing feedback to the case processing vendor.
• Proactively identify quality and compliance issues, supporting non-conformance inves-tigations.
• Perform or ensure vendor performs downloads from Authority Databases (e.g., Eu-draVigilance, Health Canada).
• Maintain and archive project sites, lists, Q&A, and trackers.
• Perform in-house ICSR reconciliation activities and support PV ICSR Managers with coordination of reconciliation activities.
• Support miscellaneous administrative tasks related to ICSR processing.Requirements :
• Education : University level qualification in biosciences, healthcare, or pharmacy.
• Experience : At least 3 years of post-graduation experience in the pharmaceutical in-dustry within Pharmacovigilance. At least 2 years of experience with case processing activities in a safety database, including triage, data entry, and MedDRA coding.
• Knowledge : Thorough knowledge of regulatory Pharmacovigilance requirements dur-ing Clinical Trials and Post Marketing, including GVP and ICH Guidelines. Good un-derstanding of database configurations and migrations. Working knowledge of Aris-Global LifeSphere MultiVigilance system is desired.
• Skills : Fluent in English (written and spoken). Strong analytical skills, ability to work proactively, independently, and collaboratively. Excellent relationship-building skills internally and externally. Sound judgment and ability to handle risks effectively.Personal Attributes :
• Ability to work effectively to deliver ambitious goals.
• Strong collaborator within PV function and the wider organization.
• Problem-solving skills and ability to escalate issues as appropriate.
• Experience in process development, implementation, training, and oversight.About the assignmentLocation : Stockholm, SwedenType : Full-Time (On-site preferred)Start Date : June 16, 2024Duration : 4-6 months with possible extensionApplication InstructionsAs the selection process and interviews are conducted continuous-ly, we warmly welcome you to submit your application as soon as possible via www.jurek.se. If you have any questions regarding the position, please contact the responsible consultant manager, Hanna Broström, at [email protected] UsJurek Recruitment & Consulting was founded in 2006 by serial entrepreneur Shervin Razani and is a growing company focused on flexible and customer-tailored recruitment and consult-ing services. We recruit and hire talents in a variety of fields, from students to experienced professionals with specialized skills. Our assignments span the areas of law, finance, HR, mar-keting / communication, administration, and management. Since every assignment is unique, we strive to always create a perfect match for our consultants and clients.Consultant at JurekIn 2024, we were named one of Sweden´s 100 most attractive employers by Karriärföretagen. It´s a great acknowledgment of our important work in offering unique career and development opportunities. As a consultant with us, you will have the chance to work at exciting workplac-es across different industries, always supported by a dedicated consultant manager who will assist you throughout your assignment and help you advance in your career. You will also be invited to several exciting networking events and activities together with consultant managers and other consultants at Jurek.Curious to know more about what it´s like to be a consultant with us? Check out what our consultants have to say here : https : / / jurek.se / konsult-hos-oss-pa-jurek