Job Description:

Manager, Risk Management (RM), Global Patient Safety & Risk Management (GPSRM)

Overview

Alnylam is the world's leading RNA interference (RNAi) company.

Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality by harnessing the power of RNAi for human health as an innovative new class of medicines. We are a growing biopharmaceutical company with two approved medicines and a robust pipeline of investigational medicines focused in four strategic therapeutic areas: genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases, including several in late-stage development.

Headquartered in Cambridge, Mass., Alnylam employs over 1,400 people in 19 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work five years in a row (2015-2019), a Great Place to Work in the U.K. and Switzerland in 2020 and Science Magazine's #1 Top Employer in 2019. Please visit www.alnylam.com for more information.

The Manager, Commercial Finance will work closely with the Commercial FP&A, Revenue Accounting and Commercial Forecasting teams globally to provide consolidated product sales planning, reporting, and analysis for Finance and Commercial areas in the company. This role will report to the Vice President of Global Commercial FP&A.

The RM Manager will report to the Director of PV Science and execute tasks supporting the development, implementation, and oversight of all aspects of Medical Safety and Risk Management (MSRM) for Alnylam investigational and marketed products. These activities include but are not limited to the following: signal detection and management, inspection readiness, planning and preparation for aggregate safety reports, responses to ad-hoc Health Authority requests, etc.

Summary of Key Responsibilities

Support development, implementation, and oversight of MSRM which include, but are not limited to the following:

• Works closely with the MSRM physicians to assist in routine and ad-hoc safety risk management activities.
• Supports the development of Risk Management Plans (RMPs), signaling and data mining activities for Alnylam products.
• Manages the GPSRM signal tracker
• Collaborates with GPSRM and cross-functional team members to assist on various projects.
• Supports tracking and documentation of all Risk Management team activities.
• Contributes to activities related to the functioning of Alnylam safety committees, including but not limited to, preparing presentations and reports, minutes and meeting documents; ensuring completion of action items;
• Contributes to the development of SOPs, work practices and guidelines, forms and templates, and other communications related to risk management and product safety.
• Supports the authoring of aggregate safety reports (e.g. PBRER, DSUR) in close collaboration with PV Scientists, safety physicians and Global Safety Operations (GSO).
• Assists in preparation of potential safety and quality risk assessment reports, such as Health Hazard Evaluation.

Qualifications

Education: Bachelor's degree required. A degree in a healthcare-related discipline preferred.

Experience:

• Must exhibit excellent planning, organization, written and verbal communication skills.

• Ability to work in a matrix environment in accordance with the company leadership commitments and values. Preferably with experience of working across diverse geographic areas, business settings and cultures.
• A minimum of two years of experience in the pharmaceutical industry strongly preferred.
• Experience in pharmacovigilance, safety or clinical science, and/or other relevant areas of clinical biopharmaceutical development or medical affairs. Specific experience in drug safety department is an advantage.
• Extensive knowledge of Microsoft Office tools: Word, Excel, Power Point, Visio
• Established skills in developing/implementing data displays (Dashboards) of data for signaling, compliance and departmental KPIs & QPIs.
• Regulatory Inspection readiness experience is an advantage.
• Experience in contract management is a plus.

Special Skills: Ability to work in fast paste, results driven environment.

Supervision: Individual is expected to work independently but also take instruction; communicate effectively and professionally; meet deadlines and work within a variety of situations in a growing, fast-paced organization.

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

Apply Now