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