Portfolio Manager managing strategic initiatives and stakeholder engagements at iA Financial Group. Ensuring alignment with strategic objectives and enhancing overall portfolio performance.
About the role
- Senior Manager overseeing aggregate safety reporting in global patient safety operations for Regeneron. Leading cross-functional collaboration and compliance in safety reporting processes.
Responsibilities
- 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
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