4 дня назад
Medical Safety Officer - Solid Tumors
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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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