Project manager in drug safety

Manage ‘Client’ or ‘Project’ specific PSS processes associated with products ( drugs and devices) including the entire adverse events process. Manage and oversee the submissions of expedited and periodic safety reports to the regulatory agencies, ECs and investigators. Responsible for providing support to clients either as a support function to the client project groups or as stand-alone business.

• Provide leadership and management of global or regional projects ensuring that communications and processes are harmonized for assigned projects.
• Monitor and manage the workflow for assigned projects to ensure all deadlines are met and compliant safety reporting in accordance with international reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team.
• Responsible for making decisions regarding adverse event reporting within the guidelines of each assigned project.
• Work closely with the clinical operations and project management groups to ensure all PSS activities are performed according to the regulatory and contractual requirements.
• Provide oversight of the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial for assigned projects.
• Entry of safety data onto adverse event database(s) and tracking systems.
• Review of adverse events for completeness, accuracy, and appropriateness for expedited reporting.
• Write patient narratives.
• Code adverse events accurately using MedDRA.
• Determine expectedness/listedness against appropriate label.
• Identifies clinically significant information missing from initial reports and ensures its collection.
• Ensure case receives appropriate medical review.
• Prepare follow-up correspondence consulting with the medical staff accordingly.
• Ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines.
• Reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Fortrea project personnel, if required, within study specified timelines.
• Provide oversight of the management and processing of expedited safety reports (ESRs) for assigned projects.
• Review and update adverse event databases and tracking systems.
• Review of patient narratives.
• Review the coding of adverse events.
• Review of reporting of ESRs and endpoints to clients, regulatory authorities, ethics committees, investigators and Fortrea project personnel, if required, within study specified timelines.
• Execute and/or ensure routine quality review of adverse event reports and aggregate reports ensuring that case processing and data quality meet global regulatory compliance standards for assigned projects.
• Complete triage, distribution checklist and quality review of all ESRs for assigned projects.
• Provide oversight and management of EudraVigilance activities for assigned projects.
• Maintain a strong understanding of Fortrea’s safety database conventions or client specific database conventions and system functionality.
• Provide oversight and/or perform signal detection and trend and pattern recognition activities, as required for assigned projects.

• Knowledge of Medical Devices and IVD vigilance
• Compliance with client and global regulatory requirements.
• Good knowledge of the relevant 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.
• Work collaboratively with PSS Management’s team.
• Good verbal, written and presentation skills.
• Good communication.
• Leadership capabilities.
• Anticipate/identify problems and takes appropriate action to correct.
• Knowledge of aggregate reporting.
• Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.
• Financially intuitive.
• Будет плюсом: Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial

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