Janssen Pharma K.K. is recruiting for a(n) Pharmacovigilance Franchise Leader, located in Tokyo HQ office.
Responsible for actual practice (implementation and accountability) of safety management procedures. Responsibilities include the collection, evaluation and reporting of safety information of the company’s investigational and marketed products in responsible therapeutic area, following company standard operating procedures (SOPs), internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations and corporate policies, and to contribute in identifying potential safety issues.
- Develop and maintain safety process with stakeholders such as spontaneous report (MR, Call Center, Partner company,…), solicited report (Clinical trial, Post marketing study), literature cases (Japanese article, foreign article) and foreign cases.
- Triage & Data entry (Quality Check)
- Triage of incoming cases to prioritize for daily workflow management
- Ensure the data accuracy in local safety database.
- Case evaluation
- Make a final safety assessment of collected information for decisions in Seriousness, expectedness and causality of safety information with due date for reporting to PMDA and GMS. Prepare follow-up query to reporters. Necessity of urgent safety measure
- Liaison with safety physicians appropriate to clarify appropriate information required for case processing and with GMS staff as appropriate for reconciliation of adverse event between local safety database and global safety database
- Participate in product risk management (pharmacovigilance plan and risk minimization activities)
- Make report to PMDA and HQ (GMS)
Compliance & CAPA:
- Complete Training
- Local and global SOPs and guidelines, relevant PV Agreements and Relevant Japanese regulations
- Participate in inspections and audits including interviews and provision of requested data
- Oversight case receipt compliance and deal with CAPA
Operational process improvement:
- Propose and implement more efficient process
- Utilize the outsourcing (CROs and venders)
- Participate in local safety database maintenance activities
- Participation in local or global project teams
• Bachelor's degree or educational equivalent in health science or other directly related field or equivalent combination of education, training or experience.
Experience and Skills:
• Understanding of medical terminology and ability to summarize medical information
• Ability to follow guidelines and procedural documents
- Oriented to quality, attention to detail and accuracy
- Manages own work: ability to prioritize, plan and organize work assignments, and able to work under strict timelines
- Ability to work both independently and in collaboration with others
- Proactive approach/uses own initiative appropriately
- Decision-making and problem-solving skills
- Flexibility and adaptability
- Positive attitude
- Pharmaceutical industry experience is preferred, with a focus on pharmaceutical safety related areas including case processing. Typically demonstrated by a minimum of 3 years pharma experience.
- Knowledge and experience with safety reporting and regulatory compliance in accordance with the Pharmaceutical Affairs Law, relevant laws, rules, guidelines including GPSP, GCP, and GVP. Experience of international safety reporting/regulations are preferred.
- Experience of working with SOPs etc preferred
• Good verbal and written communication skills in Japanese.
• English in business level.
- Good computer skills (Word, email) and familiarity with safety systems
- Knowledge or experience with Excel, PowerPoint, Visio preferred.
Janssen Pharmaceutical K.K. (7195)