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Pharmacovigilance (Pv) Systems Operations Manager - Gpse

6+ years
$133,000.00 - $228,000.00
10 Nov. 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Job Opportunity: Pharmacovigilance (PV) Systems Operations Manager - GPSE

Location: Cambridge, MA (Remote up to 100%)
Company: Takeda Development Center Americas, Inc.

This position involves managing pharmacovigilance system operations within Takeda's Global Patient Safety and Evaluation (GPSE) team. The role combines technical expertise in safety database management with responsibilities in compliance, vendor oversight, and regulatory reporting.


Position Details

Key Responsibilities

  • Oversee and execute pharmacovigilance agreements between Takeda and partners.
  • Manage vendors for expedited reporting and incoming/outgoing Individual Case Safety Reports (ICSRs).
  • Configure and maintain the Argus Safety database, including change control procedures and new system functionality testing.
  • Collaborate with PV Compliance and IT teams to ensure submission compliance and resolve system issues.
  • Train vendors and internal teams using work instructions/job aids relevant to daily operations.
  • Represent Takeda’s pharmacovigilance team in internal and external interactions professionally.
  • Conduct MedDRA updates, generate/review aggregate listings, and ensure audit preparedness.
  • Develop and deliver training sessions for system users.

Travel

  • Up to 5% travel required.

Remote Work

  • Up to 100% remote work permitted.

Qualifications

Education and Experience

  • Bachelor’s degree in a medical, scientific, or related field (or foreign equivalent).
  • 6 years of related experience, including:
    • Processing ICSRs for drugs/medical devices from various sources (clinical trials, spontaneous reports, published reports).
    • Expedited regulatory submissions and quality control activities.
    • Coordinating global ICSR reporting and distribution.
    • Configuring safety databases, including product licenses and study records.
    • Validation testing for data migrations and system upgrades.

Preferred Skills

  • Proficiency with Argus Safety database.
  • Strong understanding of global regulatory reporting requirements.
  • Experience in vendor management and conducting team training.

Compensation and Benefits

  • Salary Range: $133,000.00 - $228,000.00 annually.
  • Competitive benefits package, including healthcare, retirement plans, and more.

Application Instructions

Qualified candidates can apply through Takeda's Career Portal by referencing Job #R0137977.

Contact for Documentary Evidence

Individuals may submit evidence on this application, including information on workers, wages, or working conditions, to:
Certifying Officer
U.S. Department of Labor, Employment and Training Administration
Office of Foreign Labor Certification
200 Constitution Avenue, NW, Room N-5311
Washington, DC 20210


If you need help preparing for this role or understanding the application process, feel free to ask!