Alnylam Pharmaceuticals · 6 hours ago
Associate Director Case Management Vendor Oversight
Cambridge, MA
Full-time
Hybrid
Lead/Staff, Director/Executive
8+ years expAlnylam Pharmaceuticals is seeking an Associate Director for Case Management Vendor Oversight within Global Safety Operations. This role involves overseeing ICSR processing activities, ensuring regulatory compliance, and managing outsourced vendors while focusing on quality deliverables and process improvements.
BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics
Hiring Manager
Adam Lentz, MBA
Responsibilities
Act as lead for the Case Management Vendor Oversight (CMVO) CT team in an outsourced model for ICSR Management
Management of outsourced vendors to ensure agreed upon KPIs are met
Identification of gaps in processes, and areas in which efficiencies can be gained
Proactively coordinate development and implementation of processes and procedures in collaboration with QSC for compliance and quality metrics
Establish/maintain effective cross-functional team communication to advance quality activities of Alnylam
Interface with other Alnylam stakeholders to support ongoing state of Inspection Readiness
Oversight of Clinical Trial vendors relative to safety and regulatory compliance activities
Support the development of aggregate reports to ensure timely regulatory submission
Qualification
Required
University degree in biological or natural science or health care discipline required
A minimum of eight years relevant experience in Patient Safety activities in pharmaceutical industry
Demonstrated ability to understand, interpret, analyze, and clearly present scientific and medical data in verbal and written format (including advanced understanding and application of medical concepts and terminology)
Solid understanding of systems and reporting tools utilized to support pharmacovigilance activities
Demonstrated ability to be highly collaborative and effective in a team environment (including Safety, Clinical Development, Clinical Operations, Biostatistics and Regulatory), as well as with external colleagues for partnered products
Demonstrated ability to lead and mentor personnel
Ability to work independently, with minimal supervision
Excellent written and verbal communication skills
Solid experience in drug development process
Strong expertise in postmarketing pharmacovigilance
Solid understanding of applicable global clinical trial safety regulations and post marketing regulations and experience in participation in regulatory inspections/audits
Clinical judgment, critical thinking, and ability to interpret case information
Strong organizational skills
Experience with overseeing and coordinating work with external vendors
Ability to adapt to a rapidly changing environment
Basic knowledge of common data processing software (e.g. EXCEL, PowerPoint)
Company
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals is a biopharmaceutical company focused on the discovery, development and commercialization.
1001-5000 employees
H1B Sponsorship
Alnylam Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (18)
2021 (19)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
$4.55BKey Investors
Blackstone Life SciencesBlackstone CreditRegeneron
2025-09-09Post Ipo Debt· $661.25M
2022-09-12Post Ipo Debt· $900M
2022-03-04IPO
Leadership Team
Yvonne Greenstreet
Chief Executive Officer
Jeff Poulton
Chief Financial Officer
Recent News
Clinical Trials Arena
2026-01-16
Longevity.Technology
2026-01-14
2026-01-13
Company data provided by crunchbase