**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

Job requirements

- MD required (or equivalent); medical license maintained
- 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

Job responsibilities

**Post Market**

1. Provide medical oversight of post‑marketing pharmacovigilance for the marketed rare disease asset in line with EU GVP, FDA, and ICH requirements.
2. Perform clinical assessment, causality evaluation, and medical review of ICSRs, including complex cases from small, heterogeneous patient populations.
3. Lead or contribute to signal detection and signal management, integrating post‑marketing and real‑world data.
4. Support benefit–risk evaluation for the product, including input to safety governance and decision‑making forums.
5. Provide medical authoring and review for aggregate safety reports (PSUR/PBRER) and risk management plans
6. Contribute to safety‑driven labelling and CCDS updates, ensuring alignment with emerging post‑marketing data.
7. Support responses to Health Authority safety queries, inspections, and requests for additional safety analyses.
8. Support Medical Information and Patient Support Programs by providing safety input for scientific responses and safety escalation pathways
9. Ensure appropriate alignment between clinical and post‑marketing safety strategies, particularly when clinical trials continue post‑approval.

**Clinical**

1. Provide program/study level safety oversight for ongoing or late‑phase clinical trials
2. Participate in review of SUSARs, SAEs, and emerging safety trends from clinical development programs.
3. Provide medical authoring and review for development reports (CSR, DSUR)