Description

Lead Safety Information Management Group to manage pharmacovigilance activities incl. collecting, evaluating, and submitting safety information to relevant parties (e.g. PMDA, AZ global Patient Safety, licensing partners) and lead communication (incl. inspection for Re-examination) with HA in compliance with regulatory authority requirements, internal procedural documents and safety agreements by collaborating with outsourced vendor.

■ 応募資格(経験、資格等)/ Qualification (Experience & Skill etc.)

【経験 / Experience】

・Relevant Pharmacovigilance experience in pharmaceutical industry
・Comprehensive understanding of Pharmacovigilance regulatory requirements and business needs
・Cross-functional project team member experience
・Lead and coach the other staff to ensure prioritized objectives that focus on the critical activities and identify any potential risks/opportunities along with possible contingencies to ensure the appropriate PV activity in order to ensure the patient's safety
・Proactively participate in skill-development, coaching, and performance feedback of the other staff
・Support or lead product compliance related issue management
・Demonstrated experience in achievement of safety management, drug development or launch
・Proven leadership and project management experience

・Pharmacovigilance activities, drug development or regulatory affairs experience in/outside Japan
・Working with external bodies such as outsourced vendors and co-development companies as a leading person
・Cross-functional project team leader/member experience

【資格 / License】

・Bachelor's Degree in Science or related discipline

【能力 / Skill-set】

・Strategic Influencing - through well thought out rationale and effective communication skills, able to influence key decisions
・Assertive communication and negotiation skills - knows when and how to communicate, using strong interpersonal skills and written communications when appropriate
・Business English (Speaking level 6 or above, Achieve common understanding at the context level with customers)
・Results Focused - ability to overcome obstacles and achieve key outcomes
・Cultural Aw areness - able to work successfully in a multi-cultural environment
・Analytical Thinking - Logically breaking situations or issues down into their essential elements; carrying out diagnosis and developing solutions.
・Ability to gain commitment - effectively uses interpersonal abilities to build relationships and gain acceptance of ideas
・Builds effective partnerships - identified opportunities and takes actions to build effective relationships within team and with other areas
・Ethics - overriding commitment to integrity and high standards in self and others
・Coaching & mentoring
・Leadership capabilities
・Thorough knowledge of QC/QA (ISO and TQM) and ability to put the knowledge into practical use
・Project management skill

【語学 / Language】

英語 English:Business English (Speaking, Writing)

【キャリアレベル / Career Level】

E

【勤務地 / Work Location】

Osaka / Tokyo

Date Posted

Closing Date