Clinical Pharmacovigilance Specialist

Role & Responsibilities
• Oversee pharmacovigilance vendors and CRO partners in a sponsor environment
• Review, manage and approve SAEs, SUSARs and ICSR submissions
• Support preparation and medical review of DSURs and aggregate safety reports
• Provide safety input into clinical protocols, Investigator’s Brochures and trial documents
• Coordinate with Clinical Operations, QA and Regulatory Affairs teams
• Support inspection readiness, audits and safety governance meetings
• Manage long-term follow-up and safety activities specific to Cell & Gene Therapy trials
• Ensure compliance with ICH-GCP, ICH E2 and global PV regulations

Qualification
• Degree in Pharmacy, Life Sciences or related discipline

Experience
• Experience in Pharmacovigilance and Clinical Trials
• Prior exposure to sponsor oversight or CRO/vendor management preferred

Skills
• Strong understanding of clinical safety reporting and PV regulations
• Ability to work in cross-functional sponsor teams
• Good documentation, coordination and communication skills
• Exposure to Cell & Gene Therapy, Oncology or Rare Disease programs preferred

About the Company
This is a growing sponsor organization focused on developing innovative Cell & Gene Therapy programs, driving advanced clinical research with strong regulatory compliance and patient safety governance at its core.