Global Safety Vigilance Risk Management Lead

About the role

Santen, a Japan-originated global company focused on eye health with a presence in over 60 countries, is looking for a Global Safety Vigilance Risk Management Lead based in Singapore. The role leads the end-to-end strategy, execution and maintenance of safety vigilance activities across Santen's global portfolio, ensuring high standards of quality and consistency for medicinal products, medical devices and supplements through clinical development and commercial lifecycles, in line with international regulatory standards and internal policies.

Key responsibilities

• Prepare signal assessment documents and create action plans to mitigate or manage product risks.
• Maintain product Core Risk Management Plans (cRMP) and Company Core Safety Information (CCSI).
• Prepare aggregate safety reports such as PSURs and clinical trial documents such as DSURs and safety management plans.
• Lead the preparation of safety-related documents for NDA/MAA dossiers, coordinating with stakeholders and communicating with health authorities in the applied country and other regions.
• Contribute to R&D projects as a representative of Safety Vigilance, with scientific and strategic input.
• Support Safety Vigilance activities and projects globally, as directed by the Head of Medical Evaluation and Risk Management.

Required profile

• More than 5 years of experience in drug safety activities, such as pharmacovigilance, medical affairs, medical science liaison, regulatory affairs, R&D or clinical development.
• Bachelor's degree in Life Sciences or a related field, preferably a pharmacist.
• Experience in cross-functional and regional projects and in risk management for medicinal products.
• Familiarity with the product development process, including preparation of NDA/MAA dossiers.
• Ability to work independently or as part of a Pharmacovigilance unit within a global Safety Vigilance structure.

Required skills

• Strong English verbal and written communication.
• MS Office / Word.
• Leadership, decision-making and teamwork skills.