Michael Page Logo

Main menu

  • Home
  • Jobs+

    Browse for Jobs

    • Browse for Jobs
    • Accounting & Finance
    • Banking & Financial Services
    • Consultancy, Strategy & Change
    • Customer Service
    • Digital
    • Engineering & Manufacturing
    • Healthcare
    • Human Resources
    • Legal
    • Life Sciences
    • Marketing
    • Office Support
    • Procurement & Supply Chain
    • Property
    • Retail
    • Sales
    • Technology
    • Executive Search
    • Temp & Contracting

    Search for jobs

    Searching for a job?

    • Searching for a job?
    • Job search
    • Submit your CV
    • Career advice
    • Contracting
    • 2020 Salary Guide
    • Job Applicant Confidence Index
    • Japan's most sought after benefits
    • What makes a good corporate culture?
    • Salary Comparison Tool - Are you getting paid enough?
  • Advice+

    Career Advice

    • Career Advice
    • Career progression
    • Changing jobs
    • Interviewing
    • Productivity and performance
    • Resume and cover letter
    • Salary and negotiation
    • Work-life balance

    Management advice

    • Management advice
    • Engagement and retention
    • Hiring
    • Leadership
    • Staff development
    • Market insights
    • 2020 Salary Guide
    • Hiring in Fintech

    ABC's of Technology

    • https://www.michaelpage.co.jp/en
    • Download Humans of AI report
    • Download Humans of Blockchain report
    • Download Humans of Cybersecurity report

    Most Popular Articles

    • Most Popular Articles
    • Tips for Recruiting in Japan
    • Fintech in Japan: 2020 and Beyond
    • 7 killer questions to ask in a job interview
    • 5 tips to help you identify your next career opportunity
    • Common interview questions
    • What does a recruitment consultant do
  • Recruiting+

    Looking to hire?

    • Recruitment services
    • Recruitment services
    • Contracting Services
    • Submit Job Spec
    • Management Advice
    • 2020 Salary Guide
    • Job Applicant Confidence Index
    • Benefits that attract the best talent
    • What makes a good corporate culture?
    • Hiring in Fintech
    • Job Advertising: ReachTalent
    • Remote hiring

    Page Project Outsourcing

    • Page Project Outsourcing
    • About Page Project Outsourcing
    • Our approach
    • Our team of experts
    • Our testimonials

    Recruitment expertise

    • Recruitment expertise
    • Accounting & Finance
    • Banking & Financial Services
    • Consultancy, Strategy & Change
    • Engineering & Manufacturing
    • Healthcare
    • Human Resources
    • Legal
    • Life Sciences
    • Marketing
    • Office Support
    • Procurement & Supply Chain
    • Property
    • Retail
    • Sales
    • Technology
    • Executive Search
    • Temp & Contracting
    • Request a callback
  • Contracting+

    Contracting

    • Contracting
    • Contractors
    • Employers
  • About+

    About us

    • https://www.michaelpage.co.jp/en
    • Who we are
    • What we do
    • Work for us
    • Media Releases
    • PageGroup
    • Page Executive
    • Instagram
    • LinkedIn
    • Facebook
    • Twitter
  • Join PageGroup+

    Join PageGroup

    • About PageGroup
    • About PageGroup
    • Why choose us?
    • Your role here
    • Use your skills
    • FAQs
    • Apply now
  • Contact+

    Contact

    • https://www.michaelpage.co.jp/en
    • Find our offices
    • Looking to hire?
    • Submit your CV
    • Feedback

Language

  • 日本語
Sign In
Saved jobs (0)

Language

  • 日本語
Saved jobs (0)
Sign In
ログインまたは登録
Search for a job
Back to search

Pharmacovigilance Leader, Global Pharmaceuticals

Japan
Permanent
¥6,000,000 - ¥7,000,000
  • Apply
  • Email Job
  • Save Job

Bullet points

  • Contribute to Pharmacovigilance Operations at a Major Leading Pharma Company

  • Lead Case Management with Potential to Expand into Risk Management

About Our Client

  • Industry leading pharmaceutical company with expertise in oncology, infectious disease, immunology and neuroscience among other TAs

Job Description

Activities may include, but not limited to:

  • Case processing: completion of full case information on the database, including quality review to ensure accuracy and completeness
  • Triage of incoming cases to prioritize for daily workflow management
  • Completion of remaining case data entry (including narrative or auto-narrative), manual
    coding, label and approval
  • Preparation of SUA summary: Analysis of Similar Events Perform quality review of ICSR which includes review of source documents and ensuring that the case is accurate and that corrections to the case, if applicable, are
    incorporated
  • Liaison with Case Receipt and/or Safety Surveillance Physicians (SSP) staff as appropriate to clarify appropriate information required for case processing
  • Other activities relating to case processing as appropriate per case, including but
    not limited to:
  • Single case & end-of-study; unblinding, SAE/AE reconciliation, deviation memo preparation, deletion/admin edit requests and approvals, review protocol update request forms for accuracy
  • Supervising product-specific daily workload: prioritization and organization of team workload to maintain regulatory compliance and quality standards
  • Review managers Daily Report(s) to prioritize and ensure compliance with processing
    timeframes
  • Review regular Edit Check reports to identify processing inconsistencies and errors
  • Monitor Aggregate Reporting Calendars to ensure cases are processed in required
    timelines
  • Processes & procedures: awareness of and input to company procedures and guidance
  • Completion of all assigned training on company and GMSO procedural documents relating to
    case processing
  • Completion of training relating to relevant PV Agreements for assigned products
    Project work: participation in assigned projects, including inspection/audit readiness activities
  • Participation in local or global project teams, including on-time delivery of assigned
    responsibilities
  • Participation in inspections and audits as identified, including interviews and provision of
    requested data
  • Assistance in preparation or implementation of corrective/preventative actions relating to
    case processing
  • Mentoring & supervision: Mentoring of Case Processing (or other identified) staff, and involvement in recruitment and supervision.

The Successful Applicant

Required experience:

  • Safety evaluation work in the safety department of a pharmaceutical company
  • Individual case evaluation / knowledge and experience in Japan regulations regarding handling safety information and global reporting
  • (Ideally) experienced in negotiations with global

Required knowledge / skills:

  • Knowledge of related laws and regulations
  • Problem solving skills
  • Ability to build and improve business processes
  • Adaptability to environmental changes
  • Science educational background related scientific / medical field
  • High level of English, upper business level Japanese
  • Pro-active, self-starter with strong leadership and collaboration abilities

What's on Offer

  • Opportunity to develop career in a dynamic and innovative pharmaceutical company
Contact:
Ed Marsden
Quote job ref: 4150882
+813 6832 8981
Save Job
Apply
Pharmacovigilance Leader, Global Pharmaceuticals

Job summary

Function:Healthcare
Specialisation:Healthcare
Industry:Healthcare / Pharmaceutical
Location:Japan
Contract Type:Permanent
Salary:¥6,000,000 - ¥7,000,000
Company Type:Foreign Multinational
Consultant name:Ed Marsden
Consultant phone:+813 6832 8981
Job Reference:4150882

Similar Jobs

Director Project Management
Save Job
Permanent
View Job
ヘルスケア事業拡大/新規事業企画
Save Job
Tokyo
Permanent
¥8,000,000 - ¥11,000,000
View Job
新規事業開発(メディカル)
Save Job
Tokyo 23 Wards
Permanent
¥7,000,000 - ¥11,000,000
View Job
  •  
  • 1 of 3
  • Show More Jobs
Director Project Management
Save Job
Permanent
View Job
ヘルスケア事業拡大/新規事業企画
Save Job
Tokyo
Permanent
¥8,000,000 - ¥11,000,000
View Job
新規事業開発(メディカル)
Save Job
Tokyo 23 Wards
Permanent
¥7,000,000 - ¥11,000,000
View Job
Medical Director - Global Medical Assistance Provider
Save Job
Permanent
¥17,500,000 - ¥20,000,000
View Job
Sr. CRA
Save Job
Permanent
¥9,000,000 - ¥13,000,000
View Job
学術担当 (ペットフード)
Save Job
Tokyo 23 Wards
Permanent
¥4,000,000 - ¥5,000,000
View Job
クリニカルスペシャリスト - 東京 - がん - 看護師 - 医療機器
Save Job
Permanent
¥3,000,000 - ¥7,000,000
View Job
Business Intelligence
Save Job
Permanent
View Job
臨床獣医師募集(産業動物・勤務地:北海道)
Save Job
Hokkaidō
Permanent
¥6,000,000 - ¥10,000,000
View Job
View More Jobs

Sign up to receive job alerts

We will let you know when any new !keyword jobs are available. | We will let you know when any new !keyword jobs in !location are available.
Michael Page Logo
  • Read our BlogRead our Blog
  • Follow us on FacebookFollow us on Facebook
  • Follow us on InstagramFollow us on Instagram
  • Follow us on LinkedInFollow us on LinkedIn
  • Follow us on TwitterFollow us on Twitter
  • Watch us on YouTubeWatch us on YouTube

Navigation

  • Change country/region
  • Email disclaimer
  • Investor site
  • PageGroup corporate site
  • Privacy policy
  • Cookie policy
  • Site map
  • Site terms

Accreditations

ISO27001 Accreditation

Our Expertise

  • Accounting, Audit & Advisory, Tax and Treasury
  • Banking & Financial Services
  • Consultancy, Strategy and Change
  • Customer Service
  • Digital
  • Engineering & Manufacturing
  • Executive Search
  • Healthcare
  • Human Resources
  • IT
  • Legal
  • Life Sciences
  • Marketing
  • Procurement & Supply Chain
  • Property
  • Retail
  • Sales
  • Secretarial

Apps

Download from the App Store

 

Download from Google Play

 

Employer Centre

  • Feedback
  • Looking to hire?
  • Submit your CV
  • Tokyo office

© Michael Page International (Japan) K.K. Corporation Number 0104-01-043253 Registered Office 6F Hulic Kamiyacho Building 4-3-13 Toranomon, Minato-ku Tokyo 105-0001