Senior Manager, Aggregate Reporting Management
Regeneron
2 months ago
Remote friendly (Warren, NJ)
United States
Operations
Responsibilities:
- Manage aggregate safety reporting activities across all phases of the product lifecycle, supporting consistent, compliant, scientifically robust preparation, distribution, and submission of periodic and ad-hoc safety reports.
- Drive preparation, development, and maintenance of Aggregate Reporting deliverables (PSURs/PBRER, PAER, DSURs, Local Periodic Reports, SUSARs).
- Lead aggregate report planning, production, and distribution across GPS and other functions for US, EU, Japan, and other ICH regions, plus non-ICH regions.
- Provide expertise and guidance to authors and contributors of aggregate reports.
- Maintain compliance metrics and contribute to Quality Events and CAPA implementation for non-compliance.
- Implement structure, procedures, and tools to ensure timely, high-quality completion of aggregate reports and related deliverables.
- Develop and oversee functional specifications of data requirements for aggregate deliverables from safety and clinical databases.
- Collaborate with GPS and cross-functional teams (Epidemiology, Clinical Development, Regulatory Affairs, Statistics, etc.) to contribute to aggregate safety reports.
- Serve as subject matter expert during audits and inspections.
- Provide oversight and training to CRO activities supporting high-quality, timely aggregate reports.
- Provide functional vendor management to ensure high-quality vendor outputs.
- Develop and maintain aggregate report procedural packages (SOPs, work instructions), templates, and KPIs.
- Drive process improvement through automation and technology initiatives.
Qualifications / 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.
Preferred Skills:
- 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 to streamline process execution.
- Manage aggregate safety reporting activities across all phases of the product lifecycle, supporting consistent, compliant, scientifically robust preparation, distribution, and submission of periodic and ad-hoc safety reports.
- Drive preparation, development, and maintenance of Aggregate Reporting deliverables (PSURs/PBRER, PAER, DSURs, Local Periodic Reports, SUSARs).
- Lead aggregate report planning, production, and distribution across GPS and other functions for US, EU, Japan, and other ICH regions, plus non-ICH regions.
- Provide expertise and guidance to authors and contributors of aggregate reports.
- Maintain compliance metrics and contribute to Quality Events and CAPA implementation for non-compliance.
- Implement structure, procedures, and tools to ensure timely, high-quality completion of aggregate reports and related deliverables.
- Develop and oversee functional specifications of data requirements for aggregate deliverables from safety and clinical databases.
- Collaborate with GPS and cross-functional teams (Epidemiology, Clinical Development, Regulatory Affairs, Statistics, etc.) to contribute to aggregate safety reports.
- Serve as subject matter expert during audits and inspections.
- Provide oversight and training to CRO activities supporting high-quality, timely aggregate reports.
- Provide functional vendor management to ensure high-quality vendor outputs.
- Develop and maintain aggregate report procedural packages (SOPs, work instructions), templates, and KPIs.
- Drive process improvement through automation and technology initiatives.
Qualifications / 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.
Preferred Skills:
- 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 to streamline process execution.