Project Manager Drug Safety – Medical Device and IVD

About the role

Fortrea is looking for a Project Manager Drug Safety for medical devices and in vitro diagnostics (IVD). The role manages client- or project-specific pharmacovigilance (PSS) processes, including the full adverse events process, and oversees expedited and periodic safety report submissions to regulators, ethics committees and investigators. It also provides support to client project groups or as a standalone business, with financial oversight and audit/inspection support.

Key responsibilities

• Lead and manage global or regional projects, keeping communications and processes harmonised and meeting deadlines.
• Oversee receipt and processing of spontaneous adverse event reports and clinical trial reports, including entry into databases, MedDRA coding, patient narratives, expectedness/listedness checks and expedited reporting.
• Manage expedited safety reports (ESRs), quality review of adverse event and aggregate reports, and EudraVigilance activities.
• Perform or oversee signal detection, trend and pattern recognition, and prepare Safety Management Plans, Reconciliation Plans and pharmacovigilance reports (ICSRs, aggregate reports).
• Prepare and present safety reports to clients, regulators, ethics committees and investigators, and manage cumulative safety data for DSMBs and regulatory authorities.
• Contribute to SOPs and work instructions, train project teams, mentor colleagues, and prepare for and take part in audits.
• Monitor project deliverables, time and cost estimates, and generate monthly status reports; attend client meetings and liaise with clients.
• Support reconciliation of safety databases with Data Management or the client, and contribute to protocol, case report form and adverse event reporting form development.

Required profile

• Knowledge of medical device and IVD vigilance and worldwide pharmacovigilance regulations and guidelines.
• Good knowledge of GCP, ICH guidelines, and medical and drug terminology.
• Leadership capabilities, good verbal, written and presentation skills, and good communication.
• Ability to anticipate and solve problems, and financially intuitive.

Required skills

• Knowledge of aggregate reporting and risk management and pharmacovigilance regulatory environment.
• MS Office and Windows knowledge is beneficial.