
Senior Pharmacovigilance Officer, Team Lead – Case Processing Manager, Medical Device
Posted Aug 6

Posted Aug 6
This is a fully remote position, open to applicants in Bosnia and Herzegovina.
• Lead the team responsible for managing Individual Case Safety Reports (ICSR) for designated projects or project groups.
• Directly supervise ICSR personnel.
• Allocate tasks for assigned projects and teams and monitor workflow processes.
• Ensure effective collaboration with clients in ICSR Management.
• Contribute to the achievement of company goals and objectives.
• Offer support to project team activities on behalf of both the client and the company.
• Develop and sustain project-specific Key Performance Indicators (KPIs) for contracted ICSR activities.
• Enhance procedures, training, and actions to boost ICSR team efficiency.
• Recommend process modifications to the ICSR Operational Lead.
• Manage ICSR deviations with assistance from the ICSR Operational Lead.
• Review trackers and timesheet information to ensure accuracy.
• Engage in ICSR processing and second quality control of cases.
• Assist other departments as directed.
• Act as the designated subject matter expert for the assigned team.
• Support the Regulatory Affairs & Pharmacovigilance Network Department, serving as Local Clinical Pharmacovigilance (LCPPV) for the specified country and Pharmacovigilance Regional Language Specialist (PRLS) for the designated language.
• Graduate in life sciences, pharmacy, nursing, or another healthcare-related field, or possess relevant experience in pharmacovigilance.
• Significant previous experience in pharmacovigilance.
• At least 1 year of experience in a line management position.
• Experience in Medical Devices is mandatory.
• Exceptional written and verbal communication abilities.
• Strong organizational skills, meticulous attention to detail, and the capacity to multitask.
• Effective delegation abilities.
• Proficient planning and time management skills.
• Technical proficiency.
• Strong teamwork capabilities.
• Fluent in both spoken and written English.
• Advanced proficiency in MS Office.
• Option for remote work.
• Flexible working environment.
• Opportunities for professional growth.
• Collaborative and supportive team culture.
• Diverse and inclusive workplace.
• Professional development through involvement in clinical research, pharmacovigilance, and quality consulting.
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