9 дней назад
Medical Safety Clinician (Ophthalmology)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Medical Safety Clinician (Ophthalmology) (Medical Safety/Risk Management): Supporting safety evaluations for ophthalmology products through post-market surveillance, aggregate safety data reviews, and health hazard evaluations with an accent on clinical data classification, regulatory reporting, and risk management. Focus on analyzing clinical evaluation and literature data, coordinating vendor-supplied information, and preparing PSURs and other safety documentation in a global matrix environment.
Location: Taguig, National Capital Region (Manila), Philippines
Company
A healthcare organization developing medicines, medical technologies, and innovative solutions across the healthcare spectrum.
What you will do
- Support medical and scientific safety evaluations for assigned products.
- Prepare and coordinate post-market surveillance plans, reports, and related activities.
- Review and classify data from clinical evaluation reports, literature reviews, and surveillance activities.
- Coordinate data acquisition and preparation with vendors and support physician-led case series and data reviews.
- Assist with safety and regulatory database searches, health hazard evaluations, and product quality data reviews.
- Contribute to aggregate regulatory reports, PSURs, scientific presentations, and labeling support documents.
Requirements
- Advanced academic degree in a healthcare discipline, such as MD, DO, or ARNP.
- Previous medical device or pharmaceutical industry experience; at least 6 years of post-marketing safety data analysis is preferred.
- Knowledge of device safety, device development, pharmacology, biostatistics, and epidemiology.
- Functional knowledge of Excel, PowerPoint, and Microsoft Word.
- Strong verbal and written communication skills, with the ability to manage high workloads and critical issues under tight timelines.
- Ability to work effectively in a global, matrix environment.
Nice to have
- Ophthalmology background.
- Experience with medicines and device development and regulation.
Culture & Benefits
- Work in a patient-informed healthcare innovation environment.
- Collaborate with global, cross-functional teams.
- Contribute to treatments and technologies focused on preserving and restoring vision.
- Work in an inclusive environment that recognizes individual contribution and diversity.
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