Pharmacovigilance Clinical Project Lead

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