ICSR Case Advisor - Pharmacovigilance

Why This Role Matters

Pharmacovigilance professionals play an essential role in safeguarding patient health by monitoring the safety of medicines and ensuring timely reporting of adverse events. Accurate safety data collection, evaluation, and reporting are crucial to maintaining regulatory compliance and protecting patients worldwide.
The Japan Local Case Advisor role at AstraZeneca is particularly important because it focuses on managing safety reports related to products used in the Japanese market. The position supports Individual Case Safety Report processing, adverse event reporting, and compliance with Japanese pharmacovigilance regulations.
Working within the Global Business Services Patient Safety team, the role involves collaborating with global safety teams while ensuring that local Japanese regulatory requirements are met. This includes managing safety cases, performing data entry into safety databases, and supporting pharmacovigilance compliance activities. For professionals with pharmacovigilance experience and Japanese language proficiency, this role provides a unique opportunity to contribute to global drug safety programs while supporting patient safety initiatives for important therapeutic products.

Job Description

AstraZeneca is seeking a Japan Local Case Advisor to support pharmacovigilance operations within the Global Business Services Patient Safety function.
The selected candidate will be responsible for managing Individual Case Safety Reports and supporting safety reporting activities related to AstraZeneca and Rare Disease Unit products in Japan. The role requires proficiency in English and Japanese and involves collaboration with internal safety teams to ensure timely and accurate safety data processing. This position involves case intake activities, safety database data entry, regulatory compliance monitoring, and support for audits and inspections. The role also contributes to maintaining pharmacovigilance quality systems and ensuring adherence to Japanese regulatory standards.

Key Features of the Role

Opportunity to work in global pharmacovigilance and patient safety operations
Exposure to safety reporting for the Japanese pharmaceutical market
Involvement in Individual Case Safety Report management and adverse event reporting
Collaboration with multinational teams in a global pharmaceutical environment
Participation in pharmacovigilance quality systems and compliance activities
Opportunity to contribute to safety monitoring for innovative medicines

Responsibilities

Case Intake and Safety Reporting

Accept and validate safety reports for domestic cases in Japan and conduct preliminary case assessments. Communicate with reporters when necessary to collect additional safety information and ensure the accuracy of safety reports. Ensure proper handling of personal and confidential information in accordance with regulatory requirements and company policies. Perform routine quality checks and initiate follow-up activities when additional information is required. Collaborate with internal teams to clarify case details, triage incoming safety reports, and escalate urgent or reportable cases for further investigation.

Safety Data Entry and Case Management

Enter safety data accurately into pharmacovigilance databases and ensure that all relevant information is documented correctly. Work with internal teams to resolve data entry issues and ensure high-quality safety documentation. Initiate follow-up requests using product or event-specific questionnaires to obtain additional safety information when required.

Audit and Inspection Support

Maintain pharmacovigilance documentation in accordance with internal procedures and regulatory requirements. Support internal and external audits and assist with regulatory authority inspections by ensuring inspection-ready documentation.

Regulatory Compliance

Ensure compliance with Japanese regulatory standards for Individual Case Safety Reports and adverse event reporting. Identify urgent or high-risk cases and escalate them according to established safety procedures.

Quality Management System Support

Contribute to the effective implementation of the pharmacovigilance Quality Management System and maintain awareness of regulatory changes related to the Japanese pharmaceutical market.

General Responsibilities

Perform peer reviews of safety cases and support additional pharmacovigilance projects when required. Collaborate with internal teams on pharmacovigilance aspects related to organized data collection programs.

Required Qualifications

Educational Requirements

Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related scientific field.

Experience and Skills

1 to 2 years of experience working with safety databases or pharmacovigilance data entry. Strong attention to detail and the ability to identify sensitive personal or confidential information in safety reports. Experience working collaboratively with cross-functional teams and the ability to resolve operational issues effectively.

Language Requirements

Japanese language proficiency at N2 level or higher for listening, writing, and speaking. Reading proficiency in Japanese medical terminology and Kanji characters at N3 to N1 level. English language proficiency equivalent to A2 level according to the CEFR framework.

Technical Knowledge

Familiarity with pharmacovigilance processes and adverse event reporting standards. Experience with safety databases such as Oracle Argus Safety is preferred. Knowledge of global pharmacovigilance guidelines such as Good Pharmacovigilance Practice and Good Clinical Practice is considered advantageous. Understanding of medical coding systems such as MedDRA and WHO Drug Dictionary is beneficial.

Professional Skills

Strong problem-solving and analytical abilities. Excellent written and verbal communication skills. Ability to work effectively in multicultural teams and collaborate with stakeholders across different regions.

Salary Insights

Although the exact salary package has not been disclosed, pharmacovigilance roles within global pharmaceutical companies typically offer competitive compensation based on experience, skills, and regional policies. Employees may also benefit from professional development opportunities, exposure to global pharmacovigilance operations, and participation in international patient safety initiatives.

Company Overview

AstraZeneca is a global biopharmaceutical company focused on discovering, developing, and delivering innovative medicines that transform patient care. The company operates across multiple therapeutic areas including oncology, cardiovascular diseases, respiratory conditions, and rare diseases. AstraZeneca places strong emphasis on patient safety and regulatory compliance, supported by advanced pharmacovigilance systems and global safety monitoring programs. Through collaborative research, advanced technology, and strong global partnerships, AstraZeneca continues to develop life-changing medicines while maintaining high standards of quality and safety.

FAQs

Who can apply for this role?
Candidates with a life sciences background and pharmacovigilance experience, along with Japanese language proficiency.

Is Japanese language proficiency mandatory?
Yes. Japanese language skills at N2 level or higher are required for handling domestic safety cases in Japan.

What type of work does the Japan Local Case Advisor perform?
The role involves case intake, safety data entry, adverse event reporting, regulatory compliance monitoring, and audit support.

Is experience with safety databases required?
Experience with pharmacovigilance safety databases such as Argus is preferred.

Application Tips

Highlight your pharmacovigilance or safety data management experience in your resume.
Mention your proficiency in Japanese language and experience working with Japanese regulatory requirements.
Include experience with safety databases and adverse event reporting systems.
Demonstrate your attention to detail and ability to handle confidential information responsibly.
Showcase your ability to collaborate with global teams and manage safety case documentation accurately.