Drug Safety Program Manager

Alkermes

Waltham, MA, United States
Base: $145,000 - $158,000; bonus/equity: annual pe...
Hybrid
Clinical study safety management
Case processing and reporting
Vendor and cro oversight
The Drug Safety Manager will have primary responsibility for end-to-end safety leadership across clinical studies and marketed products

Job Summary

  • The Drug Safety Manager will have primary responsibility for end-to-end safety leadership across clinical studies and marketed products.
  • Responsibilities include clinical study safety management, case processing, vendor oversight, and ensuring regulatory compliance.
  • Alkermes offers a competitive benefits package and a hybrid working environment with 60% of time in the office and 40% from home.

Matching Summary

The Drug Safety Manager will have primary responsibility for end-to-end safety leadership across clinical studies and marketed products.

Salary

Base: $145,000 - $158,000; Bonus/Equity: Annual performance pay bonus; Benefits: Competitive benefits package

Skills & Requirements

Must-have

  • Clinical Study Safety Management
  • Case Processing and Reporting
  • Vendor and CRO Oversight
  • Regulatory Reporting Compliance
  • Safety Database Configuration

Nice-to-have

  • Proactive problem identification
  • Effective communication skills
  • Attention to detail
  • Ability to prioritize workload

Key Requirements

  • 5-7 years drug safety experience
  • Clinical degree (RPh/PharmD, BSN, RN)
  • Knowledge of regulatory safety reporting
  • Competence with safety databases
  • Ability to work independently

Work Rights

Not specified

Tailored Resume

Cover Letter