23 дня назад
Global Safety Vigilance Risk Management Lead (Pharmacovigilance)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Global Safety Vigilance Risk Management Lead (Pharmacovigilance): Leading end-to-end safety vigilance and risk management activities for medicinal products, medical devices, and supplements across clinical development and commercial lifecycles with an accent on signal assessment, risk mitigation, and regulatory dossier preparation. Focus on developing core risk management plans and safety information, preparing PSUR and DSUR reports, and providing scientific and strategic input to global R&D projects.
Location: Singapore
Company
is a Japan-originated global ophthalmology company focused on developing, manufacturing, and commercializing eye health products and services in more than 60 countries and regions.
What you will do
- Lead global safety vigilance and risk management activities for investigational and post-marketing products.
- Prepare signal assessment documents, product risk mitigation plans, core Risk Management Plans, and Company Core Safety Information.
- Develop aggregate safety reports, including PSURs, and clinical trial safety documents, including DSURs and safety management plans.
- Lead safety documentation for NDA/MAA dossiers and collaborate with stakeholders and health authorities across regions.
- Provide scientific and strategic safety input to R&D projects and support global Safety Vigilance initiatives.
Requirements
- More than 5 years of experience in drug safety or related pharmaceutical functions, including pharmacovigilance, medical affairs, regulatory affairs, R&D, or clinical development.
- Bachelor’s degree in Life Science or a related field; a pharmacy background is preferred.
- Experience in medicinal product risk management, product development, and NDA/MAA dossier preparation.
- Experience working on cross-functional and regional projects within global safety vigilance structures.
- Strong written and verbal English communication skills, with the ability to work independently and in multidisciplinary teams.
- Strong leadership, negotiation, decision-making, influencing, organizational, and MS Office skills.
Culture & Benefits
- Flexible ways of working and an inclusive physical and virtual workplace.
- Opportunity to contribute to global ophthalmology research, development, manufacturing, and commercial activities.
- Work with international teams focused on improving patient outcomes, education, and treatment.
- Accommodation support is available during the recruitment process upon request.
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