Aggerate Reports Specialist

Position Overview

We are seeking an Aggregate Reports Specialist to support pharmacovigilance and safety science activities through the preparation of aggregate safety reports, safety data review, signal detection, and risk management initiatives. This role will collaborate with cross-functional teams to support regulatory compliance, safety surveillance, and global reporting requirements.

Key Responsibilities

• Support the preparation and management of aggregate safety reports, line listings, and related regulatory deliverables.
• Coordinate aggregate report processes, timelines, and documentation.
• Review and analyze safety data to support signal detection, signal evaluation, and risk management activities.
• Support safety governance activities through report preparation, meeting documentation, and action item tracking.
• Collaborate with clinical, regulatory, medical, and pharmacovigilance teams to support safety reporting and compliance.
• Contribute to process improvements, safety documentation, metrics, and reporting activities.
• Support training and knowledge-sharing within safety operations.

Required Qualifications

• Advanced degree in Nursing, Pharmacy, Medicine, Physician Assistant studies, or a related healthcare discipline.
• 3-5+ years of experience in pharmacovigilance, drug safety, clinical safety, or related functions.
• Experience supporting aggregate safety reports and safety surveillance activities.
• Strong understanding of global pharmacovigilance regulations and regulatory reporting requirements.
• Experience working with safety databases, signal detection tools, and safety data analysis.
• Strong scientific writing, analytical, organizational, and communication skills.
• Ability to work independently and manage multiple priorities.

Preferred Qualifications

• Experience with signal detection, risk management, and safety governance activities.
• Experience supporting regulatory submissions and health authority interactions.
• Experience developing safety metrics, dashboards, or performance reporting.
• Clinical patient care experience.
• Experience working in global pharmacovigilance environments.

#MSPTalent

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [email protected].