【職務内容 / Job Description】

Safety Operation group staff is responsible for collecting, evaluating, and submitting safety information to the relevant parties (e.g., PMDA, AZ global Patient Safety, licensing partners)  in compliance  with regulatory authority requirements, internal procedural documents and safety agreements by collaborating with outsourced vendor.

Accountabilities/Responsibilities:

• Deliver training to the members who are responsible for collecting safety information (e.g., sales reps, CRAs, CROs) 
• Support creation of safety information exchange/collection process with relevant parties to facilitate comprehensive and speedy safety data exchange/collection (e.g., global interface organization, safety science, licensees/licensors, clinical study team, medical affairs)
• Create and implement case handling process that addresses to the product specific local RMPs.
• Ensure safety information is reported without delay from relevant parties.
• Ensure safety information (Marketed drug: ICSR; Investigational medicinal product: ICSR, research report, measures taken report, annual report) is submitted without delay to the relevant parties (Regulatory authority, License partners, Clinical Operation, Collaboration partners).
• Support obtaining follow-up information from relevant parties.
• Input requirements to safety systems (e.g., TODAY, CW, LogTri)
• Maintain knowledge of the disease areas for AZ marketed products and investigational products to effectively interface business and science needs to case handling
• Ensure compliance targets are continuously met
• Accommodate changes of the regulatory requirements and critical business needs
• Ensure KPI targets of outsourced vendor are continuously met (quality / performance)
• Escalate any actual/potential compliance issue to an appropriate person (e.g. the line manager) and contribute to resolve

Additional Responsibilities (for band E)

• Lead the other group staff  to standardize and visualize process
• Effectively work as a liaison in a outsourced vendor- client partnership
• Identify any potential risks/opportunities along with possible contingencies to ensure the appropriate PV activity in order to ensure relevant compliance
• Proactively participate in skill-development, coaching, and performance feedback of the other group staff
• Support or lead case handling related issue management

【応募資格（経験、資格等）/ Qualification (Experience & Skill etc)】

◆◆経験 / Experience◆◆

＜必須 / Mandatory＞

(for all bands)

• Relevant Patient Safety experience in pharmaceutical industry
• Cross-functional project team member experience

(for band E)

• 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.
• Proven leadership and project management experience
   

＜歓迎 / Nice to have＞

Preferred Experience

• Pharmacovigilance activities, drug development or  regulatory affairs experience outside Japan
• Working with external bodies such as outsourced vendors and co-development companies as a leading person

◆◆資格 / License◆◆

＜必須 / Mandatory＞

Education

• Bachelor’s Degree in Science or related discipline

◆◆能力 / Skill-set◆◆

＜必須 / Mandatory＞

(for all bands)

• Communication/negotiation skill
• Leadership skill
• Problem solution skill
• Logical thinking
• Business English (Speaking level 6 or above)
• Understanding of PMD Act, relevant regulations, GCP/GVP/GPSP and guidelines
• Basic knowledge of statistic analysis
• Expertise of medical/pharmaceutical science in general

(for band E)

• Strategic Influencing – through well thought out rationale and effective communication skills, able to influence key decisions.
• 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 Awareness – 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

◆◆語学 / Languages◆◆

＜必須 / Mandatory＞

• Business English (Speaking level 6 or above)
• Native level Japanese

＜歓迎 / Nice to have＞

For Band E

• Business English (Speaking level 6 or above, Achieve common understanding at the context level with customers)

◆◆勤務地 / Work Location◆◆

• Osaka or Tokyo

◆◆ｷｬﾘｱﾚﾍﾞﾙ / Career Level◆◆

• C or D (depends on experience)

Date Posted

15-11月-2019

Closing Date

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.