Global Safety Officer (Pharmacovigilance)

Location: Hybrid role based in Cambridge, Massachusetts or Morristown, New Jersey, United States

Compensation is determined based on demonstrated experience.

Company

R&D-driven, AI-powered biopharmaceutical organization developing medicines and vaccines through immunoscience and clinical innovation.

What you will do

• Provide pharmacovigilance, product safety, and risk management expertise to internal and external stakeholders.
• Lead cross-functional Safety Management Teams and Safety Analysis Teams, representing the safety position across product and project teams.
• Detect and assess safety signals, coordinate aggregate safety data reviews, and develop proactive safety analysis strategies.
• Develop risk management strategies and plans, monitor their effectiveness, and co-lead benefit-risk assessments.
• Contribute to regulatory submissions, health authority responses, and Advisory Committee preparation.
• Document, coordinate, review, and validate periodic safety reports, including RMP updates, IND Annual Reports, and Development Safety Update Reports.

Requirements

• M.D. degree or equivalent.
• At least 3 years of international pharmacovigilance or relevant industry experience, such as clinical development, with relevant clinical experience.
• Excellent clinical judgment and the ability to synthesize and critically analyze data from multiple sources.
• Ability to communicate complex clinical issues and analysis orally and in writing.
• Ability to develop and document sound risk assessments and demonstrate leadership in cross-functional teams.
• Fluent English, written and spoken, is required.

Nice to have

• Board certification or board eligibility for M.D. candidates.
• Proven excellence in a similar prior position may compensate for less than 3 years of international pharmacovigilance experience.

Culture & Benefits

• Supportive, future-focused environment centered on science and healthcare innovation.
• Opportunities for professional growth through promotion or lateral career moves.
• Rewards package aligned with contribution and impact.
• Healthcare, prevention, and wellness benefits.
• At least 14 weeks of gender-neutral parental leave.