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9 часов назад

Medical Safety Officer - Solid Tumors Oncology (Pharmacovigilance)

199 000 - 343 850$
Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
c1
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Medical Safety Officer - Solid Tumors Oncology (Pharmacovigilance): Leading medical safety and benefit-risk oversight for marketed and clinical-development oncology drugs with an accent on safety surveillance, signal detection, and risk management. Focus on evaluating safety data, guiding cross-functional clinical and regulatory teams, and developing risk mitigation strategies and safety documentation for global filings.

Location: Horsham, Pennsylvania; Raritan, New Jersey; or Titusville, New Jersey, United States

Annual base pay: $199,000–$343,850. The role is also eligible for an annual performance bonus.

Company

Johnson & Johnson develops healthcare solutions through its Innovative Medicine and MedTech businesses.

What you will do

  • Lead Safety Management Teams for assigned solid-tumor oncology products across clinical development and marketed use.
  • Conduct safety surveillance, signal detection, benefit-risk evaluations, and risk management activities, including RMPs and REMS.
  • Provide medical and scientific expertise to Compound Development Teams and Clinical Teams, including input into clinical protocols.
  • Contribute safety content to clinical, regulatory, and pharmacovigilance documents, including CSRs, ASRs, ISS/SCS, PBRERs/PSURs, and regulatory responses.
  • Communicate safety findings to senior leaders, medical safety councils, health authorities, prescribers, patients, and external experts.
  • Provide medical oversight for safety assessments, contractors, non-physician staff, due diligence activities, and cross-functional process improvements.

Requirements

  • MD or equivalent physician qualification with 2–5 years of pharmacovigilance or relevant clinical, medical affairs, or clinical research experience.
  • At least one year of clinical practice experience; medical specialization and board certification or eligibility are preferred.
  • Knowledge of drug development, pharmacology, clinical trial methodology, medical monitoring, drug safety assessment, and global safety regulations.
  • Experience with Good Clinical Practices, pharmacovigilance requirements in the US and EU, clinical trials, regulatory filings, and risk management plans.
  • Ability to lead global cross-functional teams, influence stakeholders, evaluate complex safety data, and communicate findings clearly.
  • Fluent written and spoken English required. Strong presentation, writing, prioritization, and deadline-management skills are needed.

Nice to have

  • Board certification or eligibility and a relevant medical specialization.
  • Experience presenting to health authorities.
  • Publication or journal article writing experience.
  • Proficiency in Microsoft Word and PowerPoint.

Culture & Benefits

  • Inclusive work environment focused on individual dignity, diversity, and merit.
  • Medical, dental, vision, life, disability, business accident, and group legal insurance may be available.
  • Pension and 401(k) savings plans may be available.
  • Eligibility for long-term incentives and performance-based annual bonus.
  • Vacation, sick time, holiday pay, and personal and family time are provided according to applicable policies.

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