Assoc Director, Global Safety Operations

Global Patient Safety and Risk Management (GPSRM) prioritizes patient safety. A comprehensive and rigorous approach to pharmacovigilance activities allows us to have a compliant global pharmacovigilance system. Alnylam GPSRM is committed to being vigilant about the safety profile of all our products. We detect, proactively assess, and manage drug risk throughout a product's lifecycle. Their commitment to continuous improvement and collaboration with healthcare professionals makes them a cornerstone in pursuing safer, more reliable healthcare environments globally.

The Associate Director, Global Patient Safety and Risk Management-Global Safety Systems will be responsible for configuring, maintaining, and supporting the use of the Global Safety Database (GSD) and other technical solutions. In addition, the role supports Global Safety System capability projects like Reporting Modules, integration with external applications, and any additional responsibilities assigned.

Key Responsibilities

* Configure/manage reporting rules in the Global Safety Database to meet reporting responsibilities (Regulators/Affliates).
* Add/manage configurations in all GPSRM applications, such as Argus Safety, Axway, Empirica, Rave Safety Gateway, and reporting tools.
* Supervise and monitor the configuration activities performed by vendors.
* Work collaboratively with other groups (e.g., IT validation, Quality Systems Validation) to implement solutions and ensure systems meet regulatory standards.
* Support Inspections and Audit preparations and prepare responses to any queries or requests.

Qualifications

* BS Computer Science/equivalent qualification with at least ten years of experience.
* Experience performing, leading, and managing Oracle Argus Safety configurations is required. Additionally, work experience with Oracle Cloud is preferred.
* Relational database knowledge working with Oracle Argus and SQL is required.
* General knowledge of the Software Development Lifecycle (SDLC) and experience performing qualification/validation (IQ/OQ/PQ) is required.
* General knowledge about the global safety reporting requirements and
ICH E2B guidelines that govern the international reporting of adverse events on investigational and marketed products are required.
* Leadership experience is required to oversee the team's daily operations, set clear goals, and ensure tasks are completed efficiently.
* General knowledge of Electronic Data Interchange is preferred (Axway B2Bi Interchange, in particular, is a plus).
* General knowledge of Rave Safety Gateway (RSG) is preferred.
* A good understanding of periodic and ad-hoc safety report development processes is preferred. Knowledge of OBIEE/PV Reports is a plus.

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 culture: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 one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 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.