【職務内容 / Job Description】

Risk Management & Safety Scientists are responsible for setting product safety specifications and for delivery of local Risk Management Plan (RMP), and J-PI (safety parts) to optimize market access from patient safety perspective in Japan.
RMP Team Leads manage setting the project safety strategy in view of ‘Benefit and Risk valance’ of each product by planning the appropriate risk minimization activities and pharmacovigilance plan including regulatory mandatory pharmacovigilance studies collaborated with JPT and Global Strategic Safety Management Team (SSaMT) Leads for JNDA preparation.
Safety surveillance representatives lead to execution of pharmacovigilance activity, and communication of Safety Assurance Measure basically during EPPV period.

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

◆◆経験 / Experience◆◆

＜必須 / Mandatory＞

• Bachelor’s or higher Degree in Science or related discipline
• Relevant safety experience or experience elsewhere in Pharmaceutical industry
• Cross-functional project team experience
• Thorough knowledge of the Pharmacovigilance or drug development process
• Written and verbal communication skills
• Scientific knowledge sufficient to understand all aspects of safety issues

＜歓迎 / Nice to have＞

• Pharmacovigilance activities, Drug development or regulatory affairs experience in outside of Japan
• Working with external bodies, such as co-marketing  companies and advisory board members, as a leading person

◆◆能力 / Skill-set◆◆

＜必須 / Mandatory＞

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

◆◆勤務地 / Work Location◆◆

• Osaka or Tokyo

◆◆ｷｬﾘｱﾚﾍﾞﾙ / Career Level◆◆

• D or E (depends on experience)

Date Posted

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.