Global Safety Vigilance Risk Management Lead

Job Description

What you will do

1. Considering impact on subject/patient safety and product value maximization from development to post-marketing stage.

2. Flexible mindset and refined negotiation skill to achieve challenging targets.

3. 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
• Leading preparation for safety relevant documents for NDA/MAA dossier in collaboration with other SV members and relevant stakeholders with deep understanding for requirements and requests in the applied country as well as submitted dossier and communication with the health authorities in other regions/countries referenced by the applied country.
• Contribute to R&D project as a representative of SV with scientific and strategic input

4. 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.

Qualifications

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.

Additional Information

Grow your career at Santen

A career at Santen is an opportunity to make a difference. We aspire to contribute to the realization of “Happiness with Vision” by providing eye health products and services to patients, consumers, and medical professionals around the world. Guided by our CORE PRINCIPLE, “Tenki ni sanyo suru”, Santen is engaged in the global research & development, manufacturing, and sales and marketing of pharmaceutical products in opthlamology. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know.