Senior PV Operations Specialist in Alderley Edge

CellCentric 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 CellCentric’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 CellCentric working across the inobrodib program, ensuring the robust oversight of CellCentric 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 CellCentric 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 CellCentric pharmacovigilance partner and other vendors, ensuring activities are conducted in accordance with CellCentric 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 delivery of responsibilities.

• Bachelor’s degree in life sciences, nursing, pharmacy, public health, or a related field (Advanced degree preferred but not required).
• Typically 5+ years of experience in pharmacovigilance, with specific experience in CRO, biotech or pharmaceutical company drug safety/clinical safety operations supporting NDA submission.
• Experience in biotech or early-stage development environments is preferred.
• Experience in both clinical trial and post-marketing safety.
• Hands-on experience with ICSR processing and global safety reporting requirements.
• Proficiency with PV safety database systems (e.g., Argus, ARISg, Veeva Vault Safety).
• Strong knowledge of global pharmacovigilance regulations (FDA, EMA, ICH, CIOMS).
• Deep understanding of MedDRA and WHO-Drug coding conventions.
• Strong attention to detail and ability to manage multiple priorities in a regulated environment.
• Proven ability to work independently and collaboratively in cross-functional teams.
• Proficiency in Microsoft Office applications (Excel, Word, PowerPoint).
• Experience with audit readiness, including leading or supporting regulatory inspections and internal audits.
• Prior experience working with vendors and/or CROs.
• Pharmacovigilance or Drug Safety certification (e.g., DIA, PV professional certifications).
• Demonstrated integrity, openness, and respect, with the ability to build trust and credibility.
• Strong accountability and consistent delivery on commitments.
• Strategic and analytical mindset, with the ability to interpret complex safety data and develop risk-benefit profiles.

• Trust and Respect: Act with integrity, honesty, and openness to build strong, credible relationships.
• Communication and Feedback: Share information clearly, listen actively, and engage in a culture of constructive feedback.
• Accountability and Reliability: Take ownership for performance, be dependable, and support others to achieve collective goals.
• Objectivity: Align on common objectives and use facts and data to reach fair, effective decisions.
• Team Balance and Enablement: Contribute to balanced roles within the team, support delegation, and help colleagues reach their full potential.

At CellCentric, we believe success is built on great teams. By embodying these working behaviors, every member contributes to a high-performing, supportive, and inclusive culture where individuals and the business thrive together. Everything we do is underpinned by our common vision and goal to improve the lives of people with cancer.

Please send your CV and covering letter to careers@cellcentric.com.