Project Manager – Drug Safety, Medical Device, IVD

🔥 3 minutes ago

🌐 Bulgaria, Italy, +2 more countries – Remote

🇧🇬 Bulgaria – Remote 🇮🇹 Italy – Remote 🇷🇸 Serbia – Remote 🇷🇴 Romania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Manage client- or project-specific pharmacovigilance and product safety processes for drugs, medical devices, and IVDs • Manage the complete adverse event process, including receipt, processing, review, coding, medical review, follow-up, and expedited reporting • Oversee submissions of expedited and periodic safety reports to regulatory agencies, ethics committees, and investigators • Lead and manage global or regional projects, harmonizing communications and processes • Monitor workflows, deadlines, regulatory compliance, SOPs, and safety processing guidelines • Oversee adverse event databases, tracking systems, EudraVigilance activities, signal detection, and trend recognition • Prepare safety management plans, reconciliation plans, pharmacovigilance reports, ICSRs, and aggregate reports • Manage project deliverables, budgets, time and cost estimates, status reports, and financial oversight • Attend client meetings and liaise with clients and internal stakeholders • Provide project training, mentoring, presentations, and support to team members • Prepare for and participate in client and regulatory audits or inspections • Manage cumulative safety data reviews, safety committees, endpoint committees, and database reconciliation • Contribute to clinical trial protocols, case report forms, adverse event reporting forms, SOPs, and work instructions • Maintain files regarding adverse event reporting requirements across countries • Cascade relevant information to PSS management and colleagues • May supervise workloads and performance of junior team members

🎯 Requirements

• Knowledge of Medical Devices and IVD vigilance • Compliance with client and global regulatory requirements • Good knowledge of worldwide pharmacovigilance regulations and guidelines • Good knowledge of Good Clinical Practice (GCP) related to clinical safety documentation • Good knowledge of ICH guidelines • Good knowledge of medical and drug terminology • Good verbal, written, and presentation skills • Good communication skills • Leadership capabilities • Ability to anticipate and identify problems and take appropriate corrective action • Knowledge of aggregate reporting • Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance • Good keyboard skills; knowledge of MS Office and Windows beneficial • Financial intuition • Ability to work collaboratively with PSS Management’s team

🏖️ Benefits

• EEO & accommodations support • Training and mentoring opportunities • Client and regulatory meeting participation • Potential supervision and leadership development opportunities

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