Project Manager – Drug Safety, Medical Device, IVD

This is a fully remote position, open to applicants in Bulgaria, +3 more countries.

📋 Description

• Oversee pharmacovigilance and product safety processes tailored to specific clients or projects for pharmaceuticals, medical devices, and in vitro diagnostics (IVDs).

• Manage the entire adverse event lifecycle, which includes receipt, processing, review, coding, medical evaluation, follow-up, and expedited reporting.

• Supervise the submission of both expedited and periodic safety reports to regulatory bodies, ethics committees, and investigators.

• Lead and coordinate global or regional initiatives, ensuring consistent communication and processes are maintained.

• Monitor workflows, deadlines, adherence to regulations, standard operating procedures (SOPs), and safety processing protocols.

• Manage databases for adverse events, tracking systems, EudraVigilance activities, signal detection, and trend analysis.

• Develop safety management strategies, reconciliation plans, pharmacovigilance reports, individual case safety reports (ICSRs), and aggregate reports.

• Handle project deliverables, budgets, time and cost projections, status updates, and financial oversight.

• Participate in client meetings and serve as a liaison between clients and internal stakeholders.

• Provide training, mentoring, presentations, and support for team members on project-related matters.

• Prepare for and engage in client and regulatory audits or inspections.

• Manage comprehensive safety data reviews, safety committees, endpoint committees, and database reconciliations.

• Contribute to the development of clinical trial protocols, case report forms, adverse event reporting forms, SOPs, and operational instructions.

• Maintain documentation concerning adverse event reporting requirements across various countries.

• Relay pertinent information to PSS management and colleagues.

• May oversee the workloads and performance of junior staff members.

⛳️ Requirements

• Familiarity with Medical Devices and IVD vigilance.

• Adherence to client and global regulatory standards.

• Strong understanding of international pharmacovigilance regulations and guidelines.

• Proficient knowledge of Good Clinical Practice (GCP) as it pertains to clinical safety documentation.

• Solid knowledge of ICH guidelines.

• Understanding of medical and pharmaceutical terminology.

• Excellent verbal, written, and presentation abilities.

• Strong communication skills.

• Proven leadership skills.

• Capability to foresee and identify issues and implement appropriate corrective measures.

• Knowledge of aggregate reporting processes.

• Awareness of the regulatory landscape concerning Risk Management and Pharmacovigilance.

• Proficiency in keyboard skills; familiarity with MS Office and Windows is advantageous.

• Financial acumen.

• Ability to collaborate effectively with the PSS Management team.

🏝️ Benefits

• Equal Employment Opportunity and accommodations support.

• Opportunities for training and mentoring.

• Participation in client and regulatory meetings.

• Potential for supervision and leadership development opportunities.