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Global Health Safety Director Lead

2 weeks ago


Saugus, Massachusetts, United States Lundbeck Full time
Job Overview

Lundbeck, a global biopharmaceutical company, seeks an experienced Global Health Safety Director Lead to join our team. This position is responsible for strategically managing the safety surveillance and risk minimization activities for assigned Lundbeck products throughout their life cycle.

Key Responsibilities
  • Safety Evidence Generation: Designing and implementing safety evidence generation strategies that drive drug safety decision-making and patient-centric risk minimization.
  • Aggregate Data Analysis: Providing scientific content and analysis of safety data for inclusion into aggregate reports, such as PSUR/PBRER, DSUR, and PADER.
  • Risk Management: Developing and implementing risk management plans, including risk minimization measures, RiskMAPS, and REMS programs.
  • Medical Review and Assessment: Accountable for medical accuracy, completeness, and quality of post-marketing and clinical trial Individual Case Safety Reports (ICSRs).
Requirements
  • Education: Accredited MD/DO (MBBS, MBChB, MBBCh)
  • Experience: 5+ years in drug safety in a biotech or pharmaceutical company
  • Skill Set: Excellent analytical skills, ability to synthesize large amounts of data, and make sound medical interpretations.
  • Regulatory Knowledge: Good understanding of local and global regulations/guidelines in pharmacovigilance and risk management, REMS programs.
Salary and Benefits

The estimated salary range for this position is $240,000 - $280,000, with eligibility for a 25% bonus target based on company and individual performance. Additional benefits include flexible paid time off (PTO), health benefits, and company match 401(k). Lundbeck offers a comprehensive benefits package to support employees' well-being and everyday life.