4 дня назад
Global Safety Officer, I&I
178 500 - 297 500$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Global Safety Officer, I&I (pharmacovigilance and clinical safety): Leading product safety strategy, signal detection, risk management, regulatory submissions, and periodic safety reporting for immunology and inflammation products with an accent on clinical judgment, safety data analysis, and international pharmacovigilance. Focus on coordinating cross-functional safety teams, assessing benefit-risk profiles, preparing health authority responses, and developing proactive safety surveillance strategies.
Location: Hybrid role based in Cambridge, Massachusetts or Morristown, New Jersey, United States
Salary: $178,500–$297,500 per year
Company
is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines through immunoscience.
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.
- Assess safety signals, coordinate aggregate data reviews, and implement proactive safety analysis strategies.
- Develop risk management strategies and co-lead benefit-risk assessments.
- Represent the safety function in regulatory submissions and prepare responses to health authority questions.
- Coordinate, review, and validate periodic safety reports and related clinical development documents.
Requirements
- M.D. degree or equivalent.
- For M.D. candidates, board certification or eligibility is preferred.
- At least 3 years of international pharmacovigilance or equivalent relevant industry experience for M.D. candidates; relevant clinical experience may be considered.
- Strong clinical judgment and the ability to synthesize and critically analyze data from multiple sources.
- Ability to communicate complex clinical issues and risk assessments clearly in writing and verbally.
- Fluent English, written and spoken, is required.
Culture & Benefits
- Supportive, future-focused R&D environment.
- Opportunities for professional growth through promotions or lateral moves.
- Employee rewards and benefits package.
- Healthcare, prevention, and wellness programs.
- At least 14 weeks of gender-neutral parental leave.
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