【Alexion Japan】Associate Director, Rare Disease Therapeutic Area Safety Lead

Principal Responsibilities

• Participate in JPT meetings as a JPT member to stay updated on the latest progress and provide expert opinions as needed to support team discussion and decision-making.
• General safety-related oversight in clinical trials, including review, assessment and/or presentation of safety data and addressing safety-related issues as they arise.
• Review and provide necessary input on program-related documents (e.g. protocols, regulatory briefing books, J-DSUR) from a clinical safety perspective
• Review and provide necessary input on relevant parts of filing documents (e.g. CTD, J-PI, RMP) to ensure integrity from a clinical safety perspective.
• Provide subject matter expertise in relation to PMDA filings including preparing responses to inquiries from the PMDA related to clinical safety in collaboration with JPTL and other JPT members.
• (When necessary) Liaise with Japan and global patient safety teams to ensure timely preparation of program-related safety documents/plans (e.g. Risk Management Plan, J-DSUR, PMS plan and safety part of J-PI)
• (When necessary) Engage in discussions with licenser companies for licensing-in products.
• (When necessary) Lead cross-program activities related to patient safety
• Demonstrate knowledge and ensure compliance with applicable PV regulations and PMDA guidelines
• Responsible for review of safety governance meeting minutes to ensure aligned understanding of global safety position.
• Collaborate with cross-funcitonal global colleagues.

Qualifications

• Minimum 7 years work experience in pharmacovigilance for drug in development phase and/or drug in reexamination period at a new drug development company. Experience at foreign-affiliated company is preferable.
• Excellent knowledge of local regulations and requirements for Patient Safety such as GVP, GPSP, and GCP.
• Experience in negotiation with MHLW/PMDA regarding pharmacovigilance-related work (RMP, PMS, EPPV, creating and managing JPI).
• Experience of GPSP and/or GVP inspection with PMDA/TMG, and Global PV audit.
• Strong skills in problem-solving, decision-making, communication, and negotiation.
• Strong project management, interpersonal, communication and presentation skills.
• English speaking  skills that enables communication with global team

Education

Bachelor’s degree or higher in medicine, pharmacy, veterinary, clinical examination, nursing.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.