[Singapore] Global Safety Vigilance Risk Management Lead

Responsibilities

• Considering impact on subject/patient safety and product value maximization from development to post-marketing stage.
• Flexible mindset and refined negotiation skill to achieve challenging targets.
• Act as Product Safety Lead with responsibility for risk management activities as below for Santen investigational and post-marketing products.
• Preparation of signal assessment documents
• Creation of action plans to mitigate/manage product risks
• Development and maintenance of product Core Risk Management Plans (cRMP) and Company Core Safety Information (CCSI)
• Preparation of aggregate safety report such as PSUR
• Development of clinical trial relevant documents such as DSUR, safety management plan, periodic risk monitoring of investigational products
• Contribute to R&D project as a representative of SV with scientific and strategic input
• In addition, provides support to SV related activities/projects globally according to the direction made by head of Medical Evaluation and Risk management at any given time.
• What you will bring to the role
• Experience in drug safety activities but not limited in PV function in pharmaceutical companies (e.g. pharmacovigilance, medical affairs, medical science liaison, regulatory affairs, R&D, clinical development, non-clinical research, etc.) for more than 5 years.
• Bachelor's degree in Life Science or a related field, preferably pharmacist.
• High compatibility with scientific and strategic way of thinking to find solution even in complicated situations.
• Experience in cross functional and regional projects (e.g. R&D project).
• Experience in risk management for medicinal product.
• Knowledge of products development process including preparation for NDA/MAA dossier.
• Familiarity with and ability to work as a stand-alone or a few members of Pharmacovigilance unit within a global Safety Vigilance Structure
• Well-organized and detail oriented, with strong verbal and written communication skills in English
• Ability to effectively participate in multi-disciplinary teams; strong hands-on leadership
• Solid decision-making skills, inter-dependent partnering skills, team-orientation and demonstrated ability to influence outcomes.
• Solid computer skills, using MS Office / Word.
• Grow your career at Santen
• If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know.

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