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4 дня назад

Medical Safety Officer - Solid Tumors

Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
UK
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Текст:
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TL;DR
Medical Safety Officer - Solid Tumors (Pharmacovigilance/Risk Management): Leading medical safety assessment and benefit-risk oversight for solid tumor medicines across clinical development and marketed products with an accent on signal detection, safety surveillance, and regulatory risk management. Focus on leading cross-functional Safety Management Teams, evaluating safety data, developing risk mitigation strategies, and contributing to clinical and regulatory documents.

Location: High Wycombe, Buckinghamshire, United Kingdom

Company

Johnson & Johnson MedTech develops healthcare solutions and medicines focused on preventing, treating, and curing complex diseases.

What you will do

  • Lead Safety Management Teams for assigned solid tumor products across clinical development and marketed use.
  • Conduct proactive safety surveillance, signal detection, benefit-risk assessments, and risk management activities.
  • Provide medical and scientific expertise to Compound Development Teams and Clinical Teams.
  • Contribute safety input to clinical protocols, risk management plans, regulatory filings, periodic safety reports, and health authority responses.
  • Communicate medical safety findings to senior leaders, health authorities, prescribers, patients, and external experts.
  • Provide medical oversight to contractors and non-physician staff and lead cross-functional safety initiatives.

Requirements

  • Physician with an MD or equivalent and 2–5 years of pharmacovigilance or relevant clinical, medical affairs, or clinical research experience.
  • At least one year of clinical practice experience; board certification or eligibility and a medical specialization are preferred.
  • Knowledge of drug development, pharmacology, clinical trial methodology, medical monitoring, benefit-risk 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, evaluate safety data from multiple sources, influence stakeholders, and communicate findings clearly.
  • Fluent written and spoken English required.

Nice to have

  • 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.
  • Opportunity to contribute to healthcare innovation across medicines and MedTech.
  • Collaboration with global clinical, regulatory, medical, and safety functions.

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