Senior Pharmacovigilance; PV Operations Specialist

Senior Pharmacovigilance (PV) Operations Specialist (UK)

Cell Centric is a clinical-stage biopharmaceutical company with a science-driven and patient-focused mission. Our drug inobrodib is a first-in-class p300/CBP inhibitor that is being developed for the treatment of multiple myeloma and other specific cancers. Our aim is to develop inobrodib as quickly and as effectively as possible for the benefit of patients.

The Senior Pharmacovigilance (PV) Operations Specialist will have prior experience in preparing the safety data package for submission to regulatory authorities (e.g. FDA, EMA) for a New Drug Application (NDA). The individual will be dynamic and a strong team player, collaborating cross-functionally with Cell Centric’s PV Partner, Clinical Research Organisations (CROs) and internal functional teams including Clinical Operations, Medical Affairs, Data Management and Biostatistics, Regulatory and Quality to maintain high standards of patient safety and regulatory compliance.

The individual will support the day-to-day operational activities of the Safety and Pharmacovigilance function at Cell Centric working across the inobrodib program, ensuring the robust oversight of Cell Centric PV Partner who are responsible for safety event processing, quality documentation, and reporting of safety information in compliance with global regulatory requirements. The individual will contribute to the success of the team and organization by delivering on role-specific responsibilities while upholding Cell Centric core working behaviors of Trust and Respect, Communication and Feedback, Accountability and Reliability, Objectivity, and Team Balance and Enablement.

• Lead the preparation, review, and submission of safety data packages for regulatory filings, including NDAs and Integrated Summaries of Safety (ISS), ensuring compliance with FDA, ICH, GVP, and other global regulatory requirements
• Provide safety surveillance across pre-approval and post-marketing phases, including signal detection, trend analysis, benefit–risk evaluation, and contribution to risk management planning
• Oversee and support pharmacovigilance operations, including end-to-end processing of Individual Case Safety Reports (ICSRs) from clinical trials, spontaneous reports, literature, medical information, and post-marketing sources, ensuring accurate data entry, coding (MedDRA, WHO-DD), narrative development, quality review, medical assessment, and compliance with global reporting timelines
• Provide oversight and governance of the Cell Centric pharmacovigilance partner and other vendors, ensuring activities are conducted in accordance with Cell Centric SOPs, study-level Safety Management Plans, and regulatory requirements
• Support the preparation, review, and submission of expedited and periodic safety reports, including SUSARs, SAEs, DSURs, PSURs/PBRERs, in alignment with defined partner responsibilities
• Maintain inspection-ready safety documentation, including case records and Trial Master File (TMF) components, and lead or support regulatory inspections, audits, and internal quality reviews from a pharmacovigilance perspective
• Support safety data reconciliation activities between pharmacovigilance databases, clinical databases, and CRO systems to ensure data integrity and consistency
• Identify, assess, and escalate safety or compliance risks in a timely manner and lead or support corrective and preventive action (CAPA) activities related to safety operations
• Collaborate cross-functionally with Clinical Operations, Data Management, Biometrics, Medical Affairs, Regulatory Affairs, Quality, and external partners to ensure accurate and timely safety data flow and effective issue resolution
• Participate in and support safety review meetings, signal management discussions, and governance forums as applicable
• Contribute to the development, maintenance, and training of pharmacovigilance SOPs, work instructions, and related training materials
• Communicate proactively and effectively with internal and external stakeholders, demonstrating ownership, accountability, and follow-through while ensuring high-quality, timely…