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【R&D】 Biopharma Saftey Science, R&D SDA セーフティサイエンス部

Ort Ōsaka, Ōsaka-fu, Japan Kita-ku, Tokyo Prefecture, Japan Anzeigen-ID R-153147 Veröffentlichungsdatum 23/11/2022

■ 職務内容 / Job Description

Post Marketing PV & Safety Scientist is responsible for leading to execution of Pharmacovigilance activities of the products basically post marketing phase including re-examination properly and timely, and for ensuring the Patient’s safety by:
- Maintaining the Risk Management plan of the products in Japan based on the PV activities’ results and other information
- When the safety issue arises, lead to define the appropriate safety measurement through the communication with the related internal parties including Global patient safety with relevant in-house members and external parties (including co-promotion company, PMDA and MHLW etc.)
- Managing quality Pharmacovigilance deliverables such as RMP(Revision), PMS (interim and final)report , J-PSUR and Re-examination package of the assigned products/projects throughout the product’s lifecycle
- Work on management of CEI/sCEI operation, PMS data management, management of EPPV, or communication of Safety Assurance Measure as PV associate member.

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

<必須 / Mandatory>

・Relevant safety experience or experience elsewhere in Pharmaceutical industry
・Cross-functional project team experience
・Thorough knowledge of the Pharmacovigilance or drug development process
- 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

【資格 / License】
<必須 / Mandatory>

Bachelor’s Degree in Science or related discipline

【能力 / Skill-set】
<必須 / Mandatory>

・Written and verbal communication skills
・Leadership skill
・ Problem solving skill
・Logical thinking
・Understanding of PMD Act, Relevant regulations, GVP/GPSP and guidelines
・Basic knowledge of statistic analysis
・Expertise of medical/Pharmaceutical science in general

【語学 / Language】
<必須 / Mandatory>

英語 English: Business English (Speaking level 6 or above)

【キャリアレベル / Career Level】
C / D / E

【勤務地 / Work Location】

Osaka or Tokyo

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 authorisation and employment eligibility verification requirements.

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