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.
