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1. 포지션: Country Safety Lead Korea
2. 계열사: 한국얀센 (Janssen)
3. 근무지: 서울시 용산구
4. 근무 형태: Regular
- Ensuring that the LOC Safety activities, related to medicinal and non-medicinal products are managed in compliance with local regulations and company policies/procedures at a local, regional and global levels and in accordance with any Product vigilance agreements with third party business partners
- Having appropriate Pharmaco vigilance and Risk management systems in place in order to assure appropriate oversight for products within its responsibility
- Ensure the pro-active Benefit Risk Management throughout product life cycle translating global safety data to insights and actions tailoring to local specificities and needs. Support activities related to safety reporting requirements as required by Marketing Authorization Holders (MAH) and/or study sponsor, as applicable.
- Managing and coaching Local Medical Safety Team (LMS)
The Korea Safety Lead will
- Ensure that systems and processes are available for collection and reporting of safety information to meet local and global requirements
- Maintain oversight on day-to-day AE inbound and outbound reporting as applicable
- Oversee data generating activities to ensure appropriate review and reporting process are included in project documents for reporting potential AEs (e.g. patient support programs, market research surveys, internet sites),
- Ensure that day-to-day PV functions are performed satisfactorily, and that optimal regulatory compliance is maintained at the LOC level.
- Maintain overall responsibility for the coordination of safety requirements as delegated by Marketing Authorization Holders (MAH).
- Act as the local PV contact person for local PV audit and inspection.
- Ensure awareness of changes in regulations which may have an impact on vigilance activities and responsibilities. Evaluate the impact on local processes and inform the appropriate global and regional groups
- Ensure adequate local signal detection process if required and ensure reporting of potential single case signals or clusters of similar events seen in case processing
- Oversee the full product portfolio, and link with local management and key stakeholders.
- Have an appropriate system of and Risk Management in place in order to assure appropriate oversight for products within its responsibility
- Review and complete country specific Annex as required according to local requirements, if applicable
- Collaborate with Medical Affairs and Regulatory Affairs team to ensure that RMP activities are completed on a timely manner
- Ensure implementation and tracking of RMP activities are in place including documentation of completed activities
- Review all risk management plans and PSURs to obtain information on the risk/benefit profile of products
- Provide Medical Safety input in pre-authorisation phase/submission-planning phase of product lifecycle to guide appropriate planning and management of RMP-related activities.
- More than 10 years of experience in PV/Medical safety related field essential; experience working in the pharmaceutical industry is strongly preferred
- Experience in conducting training
- Knowledge of PV regulations
- Experience using global safety database desirable
- Demonstrated attention to detail
- Excellent written and spoken communication and presentation skills
- Effective decision maker with the ability to assess impact of actions taken locally on the global PV system
- Fluency in written and oral English in order to facilitate communications with GMO, regional Medical, other global functions, and Health Authority
- High customer orientation
- Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
- Sound judgment, strong planning and organizational skills, and the ability to get things done
- Demonstrated strong sense of urgency
- Strong influencing skills with the ability to explain and defend a position which is in the best interests of patient safety
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