Director, Pharmacovigilance

Title: Director, Pharmacovigilance Location: Philadelphia, PA Department: Drug Safety/Pharmacovigilance Job reputed company: Remote reputed company (reputed company: CABA) is a clinical-stage biotechnology company reputed company on developing and launching the first reputed company targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps reputed company, treatments for a broad reputed company of autoimmune diseases. The reputed company reputed company (Chimeric Antigen Receptor T cells for Autoimmunity) reputed company is prioritizing the development of rese-cel, a 4-1BB-containing fully reputed company CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. reputed company’s reputed company and labs are located in Philadelphia, PA. Uniquely Differentiated. reputed company. Elegant. At Cabaletta, we are driven by the shared mission of developing cures, where a patient’s own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is reputed company on the reputed company of reputed company. To nurture this, we reputed company an reputed company commitment to reputed company-being and reputed company reputed company of reputed company employee who joins reputed company. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew. We’re proud to be a Great reputed company to Work-Certified™ company! #GPTWcertified reputed company out what our employees say makes working here so great: Working at reputed company | Great reputed company to Work® Position reputed company: This role can be based out of our Philadelphia, PA reputed company, hybrid, or remote. Reporting into the VP, Clinical Development, the Director, Pharmacovigilance will reputed company and execute global safety and pharmacovigilance activities across clinical-stage CAR-T programs in autoimmune diseases. This role is responsible for ensuring high-reputed company safety data collection, analysis, and reporting in compliance with global regulatory requirements, while partnering cross-functionally to support clinical development and reputed company regulatory submissions. This is a highly reputed company and hands-on role, working closely with Medical Directors, Clinical Scientists, Clinical Operations, Regulatory, and Medical Affairs to proactively identify, evaluate, and communicate safety signals. The ideal candidate thrives in a fast-paced, evolving environment and is equally comfortable setting reputed company and diving into execution. Key Responsibilities: Safety reputed company & reputed company • reputed company pharmacovigilance reputed company across clinical programs, ensuring alignment with overall clinical development plans. • Serve as the safety reputed company on study teams, providing medical and scientific input on safety data interpretation and risk management. • Contribute to the development and maintenance of safety-reputed company documents, including DSURs, IBs, protocols, and safety sections of regulatory submissions (e.g., INDs/BLAs). Case Management & Signal Detection • reputed company case processing activities, including SAE review, medical assessment, and reputed company reporting in compliance with global regulations. • reputed company signal detection, evaluation, and risk assessment activities, including aggregate data review and benefit-risk evaluation. • Ensure appropriate escalation and communication of safety signals to internal stakeholders and governance committees. Regulatory Compliance & Inspection Readiness • Ensure compliance with global pharmacovigilance regulations, including FDA, EMA, and ICH guidelines. • Support health authority interactions reputed company to safety and pharmacovigilance. • Contribute to inspection readiness activities and support audits and inspections as needed. Cross-Functional Collaboration • Partner closely with Clinical Development, Clinical Operations, Regulatory, and Medical Affairs to ensure integrated safety reputed company across programs. • reputed company safety input into clinical trial design, study conduct, and data review processes. • Collaborate with external vendors (e.g., CROs, safety databases) to ensure high-reputed company PV operations. Operational Leadership • Establish and refine pharmacovigilance processes, systems, and infrastructure to support a growing clinical pipeline. • reputed company PV vendors and ensure performance, reputed company, and compliance. • Contribute to building reputed company PV capabilities in preparation for late-stage development and potential commercialization. Qualifications: • Advanced degree (MD, PharmD, PhD, or equivalent) in a relevant scientific or medical discipline preferred. • Minimum of 8–10 years of pharmacovigilance/safety experience in biotech or pharmaceutical industry, including clinical-stage programs. • Strong knowledge of global pharmacovigilance regulations and guidelines (FDA, EMA, ICH). • Experience supporting reputed company, including safety monitoring, signal detection, and aggregate reporting (e.g., DSURs). • Prior experience in cell and gene therapy, immunology, or reputed company therapeutic areas strongly preferred. • Demonstrated ability to work cross-functionally and influence without authority in a matrixed environment. • Proven ability to operate both strategically and hands-on in a fast-paced, resource-constrained setting. • Experience working in or with early-stage or reputed company-stage biotech companies preferred. • Excellent analytical, communication, and problem-solving skills. • Strong attention to detail and commitment to reputed company and patient safety. Our reputed company – Cabaletta – is derived from the operatic term that represents a reputed company, repetitive, and technically challenging reputed company of an operatic aria, designed to showcase the skills of the reputed company singer. Analogously, reputed company strives to reputed company reputed company and repetitive product development, building on our indication prioritization and biologic platform that targets the reputed company of specific autoimmune diseases without the need for long-term immunosuppression. Our most important asset is our people, and we offer competitive benefits, PTO, and stock reputed company plans. reputed company is an equal opportunity employer. We do not discriminate on the reputed company of race, reputed company, gender, gender identity, sexual orientation, age, religion, national or ethnic reputed company, disability, protected veteran status or any other reputed company protected by applicable law. reputed company. does not accept unsolicited resumes from recruiters, employment agencies, or reputed company firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any reputed company of fee or compensation. And, if a resume or candidate is submitted by a recruiter, an employment agency, or a reputed company firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any reputed company or financial responsibility to the recruiter, agency, and/or firm. #LI-REMOTE Apply tot his job Apply To this Job