Pharmacovigilance Specialist (1-Year Maternity Cover)

About the role

Baxter is looking for a Pharmacovigilance Specialist for the Nordics on a 1-year maternity cover contract, based in Soborg, Denmark or Stockholm, Sweden. The specialist works with the Pharmacovigilance Manager to keep the local PV system efficient and compliant with European and national regulations, and collaborates with the UK-based PV team under a cluster model.

Key responsibilities

• Collect, document and follow up all local adverse events and other PV information according to SOPs, and send reports to Global Patient Safety (GPS) in a timely way
• Answer safety queries from GPS and health care professionals, and close and archive ADR reports
• Process SAEs from clinical trials and transmit them to GPS
• Act as local PV representative during inspections and audits, and support corrective and preventive actions
• Ensure third-party agreements include appropriate PV clauses, reconcile adverse events with third parties and notify safety signals to them
• Communicate with national competent authorities, run surveillance for new safety information and prepare highlights for the Nordic Quality Review Meeting
• Screen competent authority websites for safety signals and regulatory changes, and keep local risk minimization activities in mind
• Deliver PV training to new employees, partners and vendors, and keep training records
• Create, issue and update local PV procedures and implement global SOPs
• Monitor local compliance, open process errors and resolve non-compliance
• Collaborate with the UK team on all activities under the cluster model

Required profile

• Bachelor's degree in Life Sciences, Pharmacy, Medicine or a related field
• 3-5 years of experience in Pharmacovigilance, Drug Safety or a related healthcare/pharmaceutical role
• Fluent in Danish, Swedish and English, with strong verbal and written communication
• Attention to detail and ability to manage multiple priorities in a regulated environment
• Strong collaboration and stakeholder management skills, able to work independently and in cross-functional teams