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Manager, Pharmacovigilance (Pv), Japan

2+ years
Not Disclosed
10 Nov. 15, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Save and Sustain Lives at Baxter: Join Our Team!

At Baxter, our mission connects us deeply to the work we do. Every role contributes to positive global impact, improving outcomes for millions of patients. For over 85 years, we've pioneered groundbreaking medical innovations that transform healthcare.

Our products and therapies are integral to hospitals, clinics, and homes worldwide. Together, we create an environment where individuals thrive, inspire one another, and achieve excellence. This is where you can do your best work.

Lead Pharmacovigilance Efforts in Japan

We are seeking a Working Manager - Pharmacovigilance (PV) in Japan to ensure compliance with local regulations, global standards, and Baxter policies while acting as the Safety Control Manager. This role is pivotal in aligning safety practices with regulatory requirements and managing risk minimization activities.

Key Responsibilities

Safety Management

  • Serve as Local Safety Manager, overseeing all PV activities in line with local legislation.
  • Identify and implement local Risk Management Plan (RMP) measures and conduct safety issue surveillance.

PV Quality Systems

  • Ensure adherence to Baxter's Pharmacovigilance Quality systems, local regulations, and audit readiness.
  • Train collaborators and ensure compliance with document retention and CAPA (Corrective and Preventive Actions) processes.

Case Intake and Reporting

  • Oversee case processing and expedited submission of adverse events to authorities.
  • Maintain expertise in regulatory requirements and manage foreign case submissions.

Team and Vendor Management

  • Lead, mentor, and grow local PV personnel while managing budgets and recruitment.
  • Collaborate with vendors to ensure outsourced PV tasks meet quality standards.

Qualifications

  • Expertise in local and international pharmacovigilance regulations (e.g., GVP, Green Book).
  • Strong understanding of clinical drug development and post-marketing surveillance processes.
  • Managerial experience with small-to-medium teams.
  • Proficient in English and Japanese, including document translation.
  • Medical or pharmacy license (preferred but not required).

Why Baxter?

We value diversity and provide equal opportunities for all. If you require accommodations during the application process due to a disability, we are here to support you.

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Join us at the intersection of saving and sustaining lives, where your purpose accelerates our mission.