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On behalf of our customer – a Stockholm-based biopharma company – we are looking for an interim Safety Physician.
Location: Flexible across the Nordics, with ability to visit the Stockholm office regularly.
THE ROLE
RESPONSIBILITIES
Post Market
-Provide medical oversight of post‑marketing pharmacovigilance for the marketed asset in line with EU GVP, FDA, and ICH requirements.
-Perform clinical assessment, causality evaluation, and medical review of ICSRs, including complex cases from small, heterogeneous patient populations.
-Lead or contribute to signal detection and signal management, integrating post‑marketing and real‑world data.
-Support benefit–risk evaluation for the product, including input to safety governance and decision‑making forums.
-Provide medical authoring and review for aggregate safety reports (PSUR/PBRER) and risk management plans.
-Contribute to safety‑driven labelling and CCDS updates, ensuring alignment with emerging post‑marketing data.
-Support responses to Health Authority safety queries, inspections, and requests for additional safety analyses.
-Support Medical Information and Patient Support Programs by providing safety input for scientific responses and safety escalation pathways
-Ensure appropriate alignment between clinical and post‑marketing safety strategies, particularly when clinical trials continue post‑approval.
Clinical
-Provide program/study level safety oversight for ongoing or late‑phase clinical trials.
-Participate in review of SUSARs, SAEs, and emerging safety trends from clinical development programs.
-Provide medical authoring and review for development reports (CSR, DSUR).
COMPETENCE REQUIREMENTS
-Medical degree (MD).
-Experience in drug safety and pharmacovigilance from a Pharmaceutical Company.
-Experience with medical review of Individual Case Safety Reports and signal detection.
-Solid understanding of global pharmacovigilance regulations and clinical development.
-Experience in benefit-risk assessment and safety surveillance.
-Experience with aggregate safety reporting is an advantage.
-Ability to work cross-functionally.
-Fluent in oral and written English.
Interested? Please submit your application or contact us at Brice Group for more information.
Morgan Eilenberg, +46 73 359 05 50 morgan.eilenberg@brice.se
Adina Lekberg Salamon, +46 73 974 43 34, adina.lekbergsalamon@brice.se