Global Safety Officer, I&I

Location: Hybrid position based in Cambridge, Massachusetts or Morristown, New Jersey; US and Puerto Rico residents only.

Salary: $178,500–$297,500 per year

Company

R&D-driven, AI-powered biopharma company developing medicines and vaccines through immunoscience and an innovative research pipeline.

What you will do

• Provide pharmacovigilance, product safety, and risk management expertise to internal and external stakeholders.
• Lead cross-functional Safety Management Teams and internal Safety Analysis Teams.
• Assess safety signals, coordinate aggregate data reviews and surveillance activities, and implement proactive safety analyses.
• Develop risk management strategies and co-lead benefit-risk assessments.
• Represent the safety function in clinical development and regulatory submission teams, including responses to health authority questions.
• Coordinate and validate periodic safety reports, including RMP updates, IND Annual Reports, DSURs, and PSURs.

Requirements

• MD degree or equivalent.
• For MD candidates, board certification or board eligibility is preferred.
• At least three years of international pharmacovigilance or equivalent relevant industry experience, such as clinical development, with relevant clinical experience.
• Excellent clinical judgment and ability to synthesize and critically analyze data from multiple sources.
• Ability to communicate complex clinical issues and analysis clearly in writing and orally.
• Fluent English, written and spoken, is required.

Culture & Benefits

• Supportive, future-focused R&D environment centered on improving patient outcomes.
• Opportunities for career growth through promotion or lateral moves, including international opportunities.
• Employee rewards and benefits package.
• Healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.