- Manage Patient Safety Activities in Clinical and PMS Programs
- Keep Compliance with ICSRs Submission in Line with Global and PMDA Regulations
- European bio-pharmaceutical company, with established presence globally that is currently in the process of building out their organization in Japan.
- Build pharmacovigilance activities and provide strategic direction.
- Where required by regulations, act as local contact or local PV leader, taking active part and cooperating with the Global PV office and being active member.
- Maintain expertise in country as well as worldwide regulations and guidelines and promote increased awareness of the legislative and regulatory environment in the country.
- Develop strong partnerships within the country (e.g. Country Managers, Medical, Marketing), and above-country functions.
- Represent company pharmacovigilance and actively participate in local Pharma Association(s) and other external groups, and effectively communicate to key stakeholders of key issues that could impact PV strategies or the business.
- Accountable for all strategic PV activities for Japan.
- Serve as point of contact of Pharmacovigilance Business Line for the Country Organization.
- Active contribution to the activities relevant to the pharmacovigilance system to ensure monitoring of the safety of products and to meet regulatory requirements.
- Contact/responsible person in the country, internally and externally, for safety-related aspects and PV.
- Ensure internal regulatory/PV processes and procedures are well documented and support compliant regulatory/PV activities.
- Extensive experience in Drug Safety and /or PV . scientific background in CNS and/or immunology helpful
- Demonstrated track record in the interpretation and application of international regulations regarding safety reporting
- Sound knowledge of global policies regarding safety surveillance.
- Thorough understanding of the computerised systems to support this function.
- Strong oral and written communication skills as the individual s from diverse cultural backgrounds.
- Strong interpersonal skills, especially in individual leadership and adaptability
- Have excellent decision-making skills
- Detail oriented to aim for 100% compliance
- Experience in change management and scenario planning
- Communication with the other functions and senior leadership teams
- Solid foundation for making quick, sound decisions, based on limited information
- Ability perform trend analysis identify gaps and implement rick mitigation strategy Self starter
- Solid experience in interactions with colleagues in Japan as well as other colleagues in PVO, PVF, PVP and global PS and external health-care professionals
- Contribute to the safe development of drugs for patients with unmet medical needs in immunology/CNS areas
- Support growing organisation in Japan