About Our Client Our client is a globally recognised Contract Research Organisation (CRO) specializing in end-to-end drug development services. They partner with leading pharmaceutical and biotech companies to deliver innovative solutions in clinical research and pharmacovigilance (PV). Role Summary Qualitas is recruiting a Clinical Project Lead (CPL) specialising in Pharmacovigilance (PV) for a remote role within our client’s PV division. You will oversee global clinical projects with a focus on pre-marketing phases (Phase I-III trials), ensuring compliance, risk management, and timely delivery of safety deliverables. This role demands strong project oversight and PV expertise. Key Responsibilities * Project Leadership: * Manage end-to-end PV activities for assigned clinical projects (including ICSR processing, SAE/SUSAR reporting, signal detection, and risk management plans). * Serve as the primary PV point of contact for sponsors, investigators, and internal teams (Biometrics, Data Management, Regulatory). * Pre-Marketing Focus: * Lead safety strategy for clinical trials pre-approval, including protocol development, safety monitoring plans, DSURs, and regulatory submissions (e.g., IND/CTA). * Ensure alignment with ICH-GCP, GVP, FDA/EMA regulations, and client SOPs. * Risk & Compliance: * Proactively identify project risks, implement mitigation plans, and manage audit/inspection readiness. * Oversight of safety database setup (e.g., ARGUS, ARISg) and vendor management. * Team & Budget Management: * Allocate resources, and track project budgets/timelines. * Deliver projects on time, within scope, and to quality standards. Essential Qualifications * Education: Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field. Advanced degree (MS, PhD, PharmD) preferred. * Experience: * 3-5 years in Pharmacovigilance/Drug Safety within a CRO, pharmaceutical company, or biotech. * Proven track record managing global clinical projects in pre-marketing phases (Phase I-III). * Expertise in pre-approval safety activities: clinical trial safety management, DSMB support, protocol/SAP review, and regulatory filings. * Skills: * Mastery of PV regulations (GVP, ICH E2), safety databases (e.g., ARGUS, Veeva), and MedDRA coding. * Strong communication, and stakeholder management skills. * Ability to work remotely with global teams across time zones. * Certifications: Project management (PMP, PRINCE2) or PV (RAC, CISP) certifications are a plus