Associate Director, Case Management Vendor Oversight

Overview

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.

Summary Of Key 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.
  
  

Qualifications

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.

Strong Skills And Experience In

• 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)
  
  

Supervision: Individual is expected to manage outsourced resources, with support from CMVO and Global Safety Operations Sr. management.

U.S. Pay Range

$162,100.00 - $219,300.00

The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer 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. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

About Alnylam

We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.