Global Patient Safety & Risk Manager: Signals & Reports

Alnylam Pharmaceuticals Inc.; Cambridge (MA); On-site; USD 132,000 - 178,000; Full time

Job summary

Alnylam Pharmaceuticals Inc. is seeking a Manager, Safety & Risk Management to help develop and implement risk management for investigational and marketed products. The role partners with Safety Product Leads to oversee signal tracking, DSURs and PBRERs, and to develop robust risk management plans.

The position emphasizes cross‑functional collaboration, data visualization, and SOP development to enhance global pharmacovigilance and patient safety capabilities across regions.

Qualifications

• Education in a medical/healthcare discipline or high qualification relevant to scientific/business field.
• A minimum of 1 year in pharma with drug safety/pharmacovigilance experience.
• Knowledge of global pharmacovigilance regulatory requirements and dashboards.

Responsibilities

• Collaborate with Safety Product Leads to analyze safety issues and manage signals.
• Support risk management plans, DSURs and PBRERs with cross‑functional teams.
• Prepare aggregate safety reports and safety committee materials.
• Contribute to SOPs, data displays and risk communications.
• Engage in data mining and visualization to monitor KPI/QPIs for safety.
• Assist in regulatory inspections readiness and training materials.

Skills

Pharmacovigilance

Signal detection

Data visualization

Argus Safety

Spotfire

Cross-functional collaboration

Regulatory knowledge

Written communication

Negotiation

Education

MSN, PharmD, PA, or MD

Tools

Argus Safety

Empirica

Spotfire

Dashboards

Job description

Alnylam Pharmaceuticals Inc. is seeking a Manager, Safety & Risk Management to help develop and implement risk management for investigational and marketed products. The role partners with Safety Product Leads to oversee signal tracking, DSURs and PBRERs, and to develop robust risk management plans.

The position emphasizes cross‑functional collaboration, data visualization, and SOP development to enhance global pharmacovigilance and patient safety capabilities across regions.