Associate Director, Case Management Vendor Oversight

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Overview**

The Associate Director, Case Management Vendor Oversight (CMVO), under Global Safety Operations, will be responsible for implementing process 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. **

Key Responsibilities  **

·         Act as lead for the Case Management Vendor Oversight (CMVO) 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. **

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Qualifications  

·         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, Medical Affairs, 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)

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

About Alnylam**

Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the  RNAi Revolution  and continues to turn scientific possibility into reality. 

Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2022, one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2023 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. **

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Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law. Alnylam is an E-Verify employer. **

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