Senior Specialist, Case Management Vendor Oversight

Overview
The Senior Specialist, Case Management Vendor Oversight (CMVO), under Global Safety Operations, will be responsible for assisting the CMVO team in the execution of processes and procedures to support the oversight of ICSR processing.
Key Responsibilities

• Assist in the management of a PV service provider responsible for processing ICSRs from investigational and post-market sources.
• Assist in the oversight and tracking of service provider KPIs.
• Review processed ICSRs to ensure case quality from an operational perspective.
• Perform monitoring of the Alnylam PV safety inbox
• Interface with the Quality Operations Department to support the appropriate handling of Product Quality Complaints associated with adverse events.
• Oversee reconciliation of safety data with different stakeholders
• Collaborate with Global Safety Systems on the configuration of the Global Safety Database
• The Sr Specialist, Case Management Vendor Oversight is also responsible for helping to mentor and develop junior PV associates and clinical development staff.

Qualifications

• Academic degree in biological or natural science or health care discipline (e.g. BSN, NP, Pharm D, MSc) required.
• Minimum 3 to 4 years relevant experience (including industry experience) with a working knowledge of drug safety and risk management. drug development, ICH and FDA regulatory requirements, and standard medical coding (MedDRA, WHO DRUG).
• Working knowledge of applicable clinical trial safety regulations and post marketing regulations.
• 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).
• 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.
• Excellent written and verbal communication skills.
• Knowledge of drug development process.
• Critical thinking and ability to interpret case information.
• Strong organizational skills, including the ability to prioritize independently with minimal supervision.
• 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

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.
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.