Senior Specialist, Drug Safety

Overview

The Senior Specialist collaborates with cross-functional colleagues to support operational regulatory pharmacovigilance company policies, processes, standards and software system configuration that impact individual case safety reports, aggregate reports and downstream medical review and safety signaling activities. Maintains Pharmacovigilance global standards for relevant activities to ensure compliance and quality aligned with (software development lifecycle), and global requirements.

• Develop and maintain the necessary processes and training to ensure high quality individual case and aggregate safety reporting in accordance with pharmacovigilance (PV) policy and regulations.
• Participate in interdepartmental and cross-functional meetings to support operational and regulatory PV requirements and deliverables.
• Maintain knowledge of PV regulations related to drugs, vaccines, biologics and devices.
• Collaborate with internal and external stakeholders with processes that ensure compliance with local and global PV regulations.
• Process incoming requests from internal and external sources related to PV requirements and assist in development of an appropriate course of action and/or response.
• Assist in preparing and responding to Regulatory Agency Inspections as well as internal and external audits as applicable.
• Support integration of acquisitions, collaborations, and partnerships.
• Collaborates with MRK IT to implement and manage system improvements and updates to the safety database and systems supporting PV activities.
• Participate and/or lead in the development of processes with internal and external stakeholders to ensure quality and compliance of individual case and aggregate safety reports.
• Perform quality review of individual case and aggregate safety reports to ensure adherence to global case processing standards and regulatory requirements.
• Perform investigations of late individual case and aggregate safety reports, including root cause analysis and development of corrective and preventive action plans.
• Compile metrics for individual case and aggregate safety reports.
• Track Advent Events metrics.
• Contribute to aggregate safety reports content such as generating and/or reviewing output and patient exposure data.
• Collaborate with Business Process Owners to improve departmental efficiencies and continuous improvement.
• Monitor group mailboxes utilized for the centralization of process/subject specific inquiries.
• Serve as subject matter expert for individual case and aggregate safety report types.

• Required:
  
  Bachelor's degree or master's degree in a life science/ health care/pharmaceutical related field or MD/DO/International equivalent
• A minimum 2 years of work experience in pharmaceutical, health care, clinical trials, clinical drug development, and/or drug safety experience required.
• Advanced English - Business level

• Knowledge and understanding of Pharmacovigilance processes and regulations
• Knowledge of safety reporting data collection requirements
• Problem solving and implementation of solutions with oversight
• Experience working in a cross-functional team setting
• Strong interpersonal skills and strong communication skills
• Project management – ability to plan and coordinate work activities with others, time management skills. Able to drive projects to completion
• Strong attention to detail and production of quality work
• Proactively seeks out advice and information from others when addressing business issues
• Computer, database skills, familiar with Microsoft Office tools

• Accountability
• Adaptability
• Adverse Event Report
• Auditing
• Biopharmaceuticals
• Business Processes
• Communication
• Compliance Monitoring
• Data Analysis
• Decision Making
• Drug Development
• Drug Safety Surveillance
• Immunotherapy
• Medical Review
• Pharmaceutical Regulatory Compliance
• Pharmacovigilance
• Project Management
• Regulatory Compliance
• Regulatory Reporting
• Regulatory Requirements
• Risk Management
• Safety Procedures
• Software Development

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Merck & Co., Inc., Rahway,…