Safety Physician

About Us

Join us in helping patients with rare diseases. At Egetis Therapeutics we challenge the status quo for the benefit of those in need. We offer an open, positive and supportive culture where everyone can be their best. Through trust, we work seamlessly across functions. As an employee you are empowered and encouraged to have an entrepreneurial spirit, enjoying an organization with conscious and efficient decision-making and we take pride in our collaborative working environment! In February 2025, the European Commission approved Egetis’ Emcitate® (tiratricol) as the first and only treatment of peripheral thyrotoxicosis in patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan-Herndon-Dudley syndrome). In March 2026, the U.S. FDA accepted the filing of Egetis’ New Drug Application (NDA) for Emcitate® (tiratricol) for the treatment of MCT8 deficiency and granted Priority Review. The Prescription Drug User Fee Act (PDUFA) target action date is September 28, 2026.  As a courageous, committed, and collaborative organization, we are seeking to grow our team to drive success both in the pre-launch and post launch phases of our anticipated U.S. approval. For more information, please visit our website at www.egetis.com or follow us on LinkedIn and Facebook  

Our Values  

• Courageous - Challenge the status quo for the benefit of the patient 
• Committed - Operate with high ethical standards through an efficient organization to deliver top quality results  
• Collaborative - Through trust, work seamlessly across functions and with external partners  

As a Safety Physician you will focus on medical oversight of clinical and post‑marketing safety, including leading on the continuous evaluation of our products benefit–risk. You will report to the Head of Patient Safety and play a critical role in our safety ecosystem. You will work closely with colleagues within the Chief Medical Office, but also with colleagues in other R&D functions and across the enterprise.   Egetis headquarters is in Stockholm, Sweden, and we welcome applications from candidates based anywhere within the Central European timezone (CET/CEST) with no relocation required. Stockholm-based or near-by area applicants are equally welcome to work from our office. 

Requirements

• MD required (or equivalent); medical license maintained or MD with extensive pharmacovigilance experience 
  • clinical research and/or fellowship training in pediatric medicine or other relevant specialty is a plus
• Minimum 3 years of Drug Safety/Pharmacovigilance (PV) experience or 3 or more years clinical development experience. Other relevant experience may be considered

Responsibilities

Post Market

• Provide medical oversight of post‑marketing pharmacovigilance for the marketed rare disease 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

• Serve as the medical safety lead for clinical trials, collaborating closely with the study lead (Clinical Development) on all safety aspects of the study conduct (safety oversight) and study protocol, including inclusion/exclusion criteria, dose modification rules, and stopping criteria, adverse events of special interest, events of clinical interest, etc. 
• Author or co-author the Safety Monitoring Plan for new clinical studies.
• Develop the Data and Safety Monitoring Board (DSMB) charter (if applicable) and serve as the primary sponsor medical contact for the DSMB.
• 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)