Company Description
Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world.
POSITION PURPOSE
- Lead the planning, preparation of strategy, maintenance and execution of safety vigilance (SV) activities to realize high quality and consistency of Santen's products (medicinal products, medical devices, supplements etc.) globally at both the development and commercial stages.
- Risk Management Leads in Pharmaco-Epidemiology group are responsible for ensuring that global risk management, operation and compliance for Santen Medicines is appropriate in terms of structure and performance, to comply with global standards, policies and procedures related to Safety vigilance.
- Additionally, the Risk Management Lead will ensure the cohesion and proper communication of information within the therapeutic or project team function for which he/she will have responsibility regardless of regions. He/she will also direct the project team members to fulfil their responsibilities to the different Santen functions such as clinical, regulatory, and others as needed.
Job Description
- Considering impact on subject/patient safety and product value maximization from development to post-marketing stage.
- Flexible mindset and refined negotiation skill to achieve challengeable 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
- Preparation for safety relevant documents at NDA/MAA dossier in cooperation with other SV members and relevant stakeholders
- 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 Pharmaco-Epidemiology at any given time.
Qualifications
- 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. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. 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.
