Drives preparation, development and maintenance of Aggregate Reporting (i.e., PSURs/PBRER, PAER, DSURs, Local Periodic Reports, SUSARs) Deliverables
Leads Aggregate Report planning, production and distribution activities across GPS and other functions across US, EU, Japan and other ICH regions, as well as non-ICH regions
Provides expertise and guidance to authors and contributors of aggregate reports
Maintains compliance metrics and contributes to implementation of Quality Events and Corrective Action and Preventive Action (CAPA) for non-compliance
Implements effective structure, procedures and tools to ensure aggregate reports and other functional deliverables are completed timely and with high quality
Develops and oversees functional specifications of data requirements for aggregate deliverables from the safety and clinical databases
Collaborates with Global Patient Safety (GPS) and with other functional areas (Epidemiology, Clinical Development, Regulatory Affairs, Statistics, etc.) contributing to aggregate safety reports
Acts as subject matter expert during audits and inspection
Provides oversight, and training as needed of CRO respective activities in support of high quality and timely aggregate reports
Acts as a functional vendor management overseeing and driving high quality outputs from our vendors
Develops and maintains aggregate report procedural package (SOPs, Work Instructions), reports’ templates, KPIs
Drives process improvement through automation and other tech initiatives.

Requirements

Bachelor’s degree required (advanced degree or HCP‑focused background preferred)
5+ years of Pharmacovigilance experience, with a demonstrated focus on Aggregate Safety Reporting
Project management experience strongly preferred, PMP preferred
Experience with health authority inspections (PV and GCP)
Medical writing experience with regulatory documentation
Strong project management skills
Excellent strategic decision-making and analytical skills
Strong communication and writing skills
Strong understanding of Scientific content
Proven experience with technology implementations allowing for streamlined process execution

Benefits

health and wellness programs (including medical, dental, vision, life, and disability insurance)
fitness centers
401(k) company match
family support benefits
equity awards
annual bonuses
paid time off
paid leaves (e.g., military and parental leave) for eligible employees at all levels

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Aggregate ReportingPharmacovigilanceMedical writingProject managementData requirements analysisQuality EventsCorrective Action and Preventive Action (CAPA)Process improvementAutomationRegulatory documentation

Soft Skills

Strategic decision-makingAnalytical skillsCommunication skillsWriting skillsCollaborationLeadershipTrainingOversightVendor managementExpertise guidance

Certifications

Bachelor's degreePMP certification