【AstraZeneca】【R&D】Senior Scientist/Study Manager, Patient Safety Evidence Generation Dept., Japan Patient Safety Division

Job Description

The PS Study Manager (PSSM) is responsible for project management to effectively deliver Post-Authorization Regulatory Commitment Studies (PARCS) using Post-Marketing Surveillance (PMS) and medical databases in alignment with time, cost, quality, and expectations.
The PSSM manages project budgets, selects third-party vendors, oversees project risk management, and ensures the delivery of project milestones. Additionally, the PSSM ensures that studies are conducted in compliance with GPSP regulatory requirements and contributes to the necessary reporting and explanations to regulatory authorities by the study team.
The PSSM may act as a proxy for the PS Evidence Lead or the PS Epidemiologist, substituting in activities such as strategic evidence planning and other study lead functions.
**Study Execution/Publicizing Study Results**
•    Develop execution project plans for PARCS based on RMP and regulatory requirements.
•    Lead vendor selection and contract negotiations.
•    Lead regulatory processes, including epidemiological consultations.
•    Engage with internal and external stakeholders.
•    Manage the activities of external service providers (ESPs).
•    Oversee the activities of the primary study implementation department to ensure deliverables are completed on time.
•    Manage the progress of study milestones.
•    Manage budget execution.
•    Prepare and report periodic reports to regulatory authorities.
•    Oversee the preparation of interim and final reports.
•    Lead the planning and execution of external presentations.
•    Lead GSPS compliance investigations and re-examination applications.

**Team Working**
Serve as the Study Manager (SM) of cross-functional study teams, working with members to ensure research activities are executed as planned.

Requirements

経験 Experience

<必須 Mandatory>

• Qualified degree in Pharmacy/ Medical/ Science
• Understanding of relevant regulations such as GVP/GPSP
• Understanding of PMS and DB study planning 
• Scientific knowledge sufficient to understand all aspects of drug safety.
• Project Management skill
• Results Focused – ability to overcome obstacles and achieve key outcomes.
• Analytical Thinking - Logically breaking situations or issues into their essential elements.
• Business English and fluent in Japanese
• Ethics – overriding commitment to integrity and high standards in self and others.

<歓迎 Nice to have>

• Advanced scientific degree in Epidemiology
• Hands-on experience in database research
• Extensive Pharmacovigilance Knowledge 
• Problem-solving, Influencing, and Conflict Resolution skills.
• Logical thinking 
• Problem solution skill
• Ability to gain commitment – effectively uses interpersonal abilities to build relationships and gain acceptance of ideas.
• Carrying out diagnosis and developing solutions.

語学 Languages

<必須 Mandatory>

日本語 Japanese：Native

英語 English：Business  Level(日常会話ができるレベル以上)

Career Level : D