Abeona Therapeutics Inc. (ABEO) is a clinical-stage biopharmaceutical company developing cell & gene therapies for serious and life-threatening diseases. We have filed a biologics license application (BLA) for our lead gene-therapy asset: pradamegene zamikeracel (pz-cel) intended for the treatment recessive dystrophic epidermolysis bullosa (RDEB), an ultra-rare debilitating skin disease. BLA is currently under priority review by the US FDA with an anticipated approval date May 25, 2024.

　　We are looking for an experienced, collaborative, and passionate and experienced Sr. Manager or Associate Director, Drug Safety/PV. You will report to the SVP, Chief Medical Officer, support all aspects of drug safety for our cell and gene therapy programs. The successful candidate will play a critical role in ensuring the safety of our patients by proactively monitoring and assessing adverse events, as well as working cross-functionally to ensure compliance with regulatory requirements.

　　General Essential Duties and Responsibilities:

　　Develop and implement comprehensive drug safety/PV plans for all clinical and post-marketing stages of our cell and gene therapy programs.

　　Manage the adverse events collection, documentation, and analysis of all relevant safety data.

　　Ensure timely and accurate processing, evaluation and reporting of adverse events.

　　Conduct signal detection and risk minimization activities to identify and mitigate potential safety concerns.

　　Authoring/reviewing  periodic safety reports (e.g., DSURs, PSURs, PBRERs, PADERs etc.) in collaboration with other cross-functional teams to health authorities.

　　Develop and maintain relationships with key stakeholders, including investigators, clinical research organizations, safety vendors and regulatory agencies.

　　Stay current on the latest regulatory requirements and scientific advancements in the field of drug safety in relation to cell and gene therapy.

　　Develop and implement strategies for pharmacovigilance and risk management of commercially launched products.

　　Provide advice and guidance to other departments on safety matters.

　　Contribute to the development and improvement of company drug safety/PV processes and systems.

　　Authoring/reviewing drug safety/PV SOPs.

　　Participate in ongoing clinical trials/registries as a drug safety representative to the study teams.

　　Participate in DMCs/DSMBs as a drug safety representative.

　　Participate in FDA's Bioresearch Monitoring (BIMO) inspection of safety related data.

　　Maintaining safety database in collaboration with safety vendors.

　　Qualifications:

　　PharmD, PhD or MS degree preferred.

　　BSN/RN or BS degree in clinical research, drag safety/pharmacovigilance, or a related health related field required.

　　5+ years of experience in the biotechnology or pharmaceutical industry with a primary focus on Drug Safety/PV post-approval. Additional Safety/PV experience in the clinical development phase will be a plus.

　　Experience working in autologous cellular therapy is preferred.

　　Strong experience with relevant drug safety databases and software.

　　Strong understanding of global regulatory requirements for cell and gene therapy products.

　　Proven experience in adverse event case management, signal detection, periodic safety reporting and risk minimization activities.

　　Excellent communication, interpersonal, and leadership skills.

　　Ability to work effectively in a fast-paced environment and manage multiple priorities.

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