Associate Director, Case Management Vendor Oversight

Alnylam Pharmaceuticals

2d

About The Position

The Associate Director, Case Management Vendor Oversight (CMVO), Global Safety Operations is responsible for implementing processes and procedures to support the oversight of ICSR processing activities as well as maintaining regulatory compliance. This role is responsible for the technical development of personnel and ensuring the quality of deliverables within their purview.

Requirements

• Education: University degree in biological or natural science or health care discipline required.
• Experience: 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)

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.

Benefits

• comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match
• Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks.
• We also offer generous family resources and leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 1,001-5,000 employees