1 день назад
Medical Safety Officer - PALM
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Medical Safety Officer - PALM (Pharmacovigilance): Leading medical safety and benefit-risk oversight for marketed and investigational medicines 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 for global drug programs.
Location: High Wycombe, Buckinghamshire, United Kingdom; additional posting location: Beerse, Antwerp, Belgium
Company
Johnson & Johnson MedTech develops healthcare solutions and medicines intended to prevent, treat, and cure complex diseases.
What you will do
- Lead Safety Management Teams for assigned marketed and investigational products.
- Conduct proactive safety surveillance, signal detection, benefit-risk assessments, and risk management activities.
- Provide medical and scientific expertise to Compound Development Teams, Clinical Teams, and clinical protocol design.
- Contribute safety input to risk management plans, clinical trial documents, regulatory filings, periodic safety reports, and health authority responses.
- Communicate important safety and benefit-risk findings to internal leadership, health authorities, prescribers, patients, and external experts.
- Oversee contractors and non-physician staff preparing safety evaluations and lead cross-functional process improvement initiatives.
Requirements
- Physician with an MD or equivalent qualification.
- 2–5 years of pharmacovigilance or relevant clinical research, Medical Affairs, or clinical experience.
- At least one year of clinical practice experience.
- 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.
- Fluent written and spoken English required.
Nice to have
- Board certification, board eligibility, or equivalent.
- 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.
- Collaboration across global medical safety, clinical, regulatory, and business functions.
- Opportunity to contribute to healthcare innovation and the safe use of medicines.
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