Aggregate Reports Specialist

Are you an experienced Pharmacovigilance professional with a strong background in authoring Aggregate Reports? We are seeking a highly skilled Aggregate Reports Specialist to join a global drug safety team, supporting critical periodic safety reporting activities across a diverse product portfolio.
This is an excellent opportunity for someone who thrives in a fast-paced, collaborative environment and has extensive experience managing end-to-end aggregate report deliverables.
Key Requirements
✅ 9-10+ years of Pharmacovigilance experience
✅ Extensive hands-on experience authoring end-to-end Aggregate Reports, including:
PBRERs (Periodic Benefit-Risk Evaluation Reports)
Addenda to PBRERs
ACOs (Ad Hoc Safety Reports)
Other aggregate safety and regulatory reports
✅ Strong understanding of global pharmacovigilance regulations and guidelines, including ICH requirements
✅ Proven experience managing report timelines, stakeholder engagement, and quality review activities
✅ Excellent attention to detail with strong analytical and problem-solving skills
✅ Demonstrated ability to mentor, coach, and support junior team members
Responsibilities
As an Aggregate Reports Specialist, you will be responsible for delivering high-quality aggregate safety reports while partnering with cross-functional stakeholders across Drug Safety, Medical Affairs, Regulatory Affairs, Epidemiology, and Clinical teams.
Key responsibilities include:
Authoring and managing end-to-end aggregate reports and ad hoc safety deliverables
Planning, coordinating, and executing report activities to meet regulatory timelines
Conducting data searches and analyses using safety databases
Reviewing source documentation and draft reports for accuracy, consistency, and compliance
Interpreting and addressing regulatory authority comments and reviewer feedback
Performing quality control reviews and identifying opportunities for continuous improvement
Supporting aggregate report planning, tracking, and maintenance activities
Monitoring report schedules and ensuring delivery milestones are achieved
Providing guidance, coaching, and mentoring to junior colleagues
Participating in cross-functional initiatives and process improvement projects
Identifying risks, escalating issues proactively, and driving resolutions with stakeholders
What We're Looking For
Bachelor's degree in Life Sciences, Biomedical Sciences, Pharmacy, Nursing, or a related discipline
Strong understanding of global pharmacovigilance regulations and safety reporting requirements
Experience working within matrixed global organizations
Excellent written and verbal communication skills
Strong stakeholder management and project coordination abilities
Proficiency with Microsoft Word and Excel
Ability to manage multiple priorities while maintaining high-quality standards
Preferred Skills
Experience reviewing and quality-checking aggregate reports
Strong understanding of benefit-risk evaluation principles
Experience supporting audits, inspections, and compliance activities
Familiarity with signal detection, safety surveillance, and risk management processes
Training and mentoring experience within Pharmacovigilance teams

Work arrangement
Yes