4 дня назад
Product Safety Head (Sr Director) - Solid Tumors
196 000 - 342 700$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Product Safety Head (Sr Director) - Solid Tumors (Pharmacovigilance/Oncology): Leading product safety strategy and risk management for marketed and developmental pharmaceutical products with an accent on oncology, clinical safety assessment, and regulatory compliance. Focus on evaluating safety data, directing Medical Safety Officers and safety scientists, managing risk mitigation, and communicating safety findings to health authorities and senior leadership.
Location: Raritan, New Jersey, United States of America; additional job posting locations include Horsham, Pennsylvania, and Titusville, New Jersey.
Salary: $196,000–$342,700 base pay per year.
Company
Johnson & Johnson MedTech develops healthcare solutions and pharmaceutical products across medical technology and innovative medicine.
What you will do
- Shape product safety strategy and risk management for assigned pharmaceutical products across development and post-marketing stages.
- Lead and provide medical oversight to Medical Safety Officers and safety analysis scientists.
- Evaluate clinical trial, post-marketing, and literature data to identify emerging and known safety risks.
- Contribute to regulatory documents, aggregate safety reports, labeling committees, risk management plans, and health authority responses.
- Partner with clinical, medical affairs, regulatory, pharmacovigilance, and research leaders on safety commitments and process improvements.
- Support inspections, CAPAs, SOP development, resource planning, and organizational talent development.
Requirements
- Physician (MD or equivalent) with 10 or more years of substantial pharmaceutical industry experience; clinical experience is highly preferred.
- Management experience supervising employees and demonstrated leadership in a global, matrix environment.
- Significant expertise in clinical medicine, pharmacovigilance, post-marketing safety assessment, and oncology products.
- In-depth knowledge of drug development, pharmacology, clinical trial methodology, medical monitoring, benefit-risk assessment, and global regulatory requirements.
- Experience handling complex safety issues, clinical safety data, regulatory interactions, and cross-functional communication.
- Fluent written and spoken English is required.
Nice to have
- Oncology therapeutic area experience.
- Publication and journal article writing experience.
- Experience presenting to technical and lay audiences at public meetings.
- Knowledge of Microsoft Excel and Word.
Culture & Benefits
- Inclusive environment focused on diversity, equity, and inclusion.
- Benefits may include health insurance, savings and pension plans, disability coverage, and long-term incentives.
- Paid vacation, sick time, holidays, and work, personal, and family time off may be available.
- Emphasis on ethical conduct, patient safety, collaboration, and employee development.
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