Job Overview:
The Aggregate Report Specialist is responsible for supporting core pharmacovigilance deliverables, including scheduled and ad hoc aggregate reports, while ensuring high-quality, timely execution of assigned activities. The role involves collaboration with cross-functional stakeholders, quality review of reports, mentoring junior team members, and supporting process improvement initiatives.
Key Responsibilities:
Support the preparation, review, and coordination of aggregate reports, including PBRERs, PADERs, line listings, and other safety deliverables.
Conduct database searches and provide data analysis to support report generation and quality review activities.
Perform quality review of reports and source documentation, ensuring accuracy, compliance, and timely resolution of reviewer comments.
Collaborate with Global Safety, Regulatory Affairs, Medical Writing, Signal Detection, Epidemiology and other cross-functional stakeholders.
Monitor report timelines and calendars, escalate risks, and support project management activities.
Coach and mentor junior team members, identify training needs, and contribute to quality improvement initiatives and CAPA activities.
Participate in team meetings, training, audits, inspections, and other departmental initiatives.
Qualifications (Minimum Required):
First degree in life sciences.
Fortrea may consider relevant and equivalent experience and successful project outcomes in lieu of educational requirements.
Extensive knowledge of global regulatory guidance (ICH, FDA, EMA) and demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines
Proficiency with document management systems, Microsoft Office suite, including MS Project and MS PowerPoint, and other software/applications commonly used in industry for clinical, regulatory, and scientific communications activities.
Excellent command of written and spoken English.
Ability to independently lead writing projects, apply critical and strategic thinking, author content de novo, and proactively seek out resources to frame structure, format, and support content for messaging (including cases in which there is no current template or standard format).
Strong organizational, project management, project team management, critical thinking, analytical, and communication skills.
Excellent knowledge of statistical concepts, clinical research principles, and medical/scientific messaging and terminology.
Required Experience & Skills:
Bachelor's degree in Life Sciences, Biomedical Sciences, Pharmacy, or a related field.
6-10 years of pharmacovigilance experience.
Hands-on experience with aggregate reports such as PBRERs, PSURs, PADERs, Addenda to PBRERs, and related safety reports.
Strong knowledge of global pharmacovigilance regulations and ICH guidelines.
Excellent attention to detail, data review/QC capabilities, and problem-solving skills.
Strong stakeholder management and cross-functional collaboration experience.
Proficiency in Microsoft Word and Excel.
Strong written and verbal English communication skills.
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