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Sr. Specialist, Case Processor

0-2 years
Not Disclosed
10 Jan. 3, 2025
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

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We’re Growing—Grow With Us!
Are you looking for a dynamic company that offers exciting challenges and growth opportunities every day?

PharmaLex is a global leader in pharmaceutical consulting, specializing in drug and medical device approvals, market development, and comprehensive product lifecycle management.

We are hiring a Sr. Specialist, Case Processor for multiple locations.


Sr. Specialist, Case Processor


Your Job Responsibilities

Core Tasks:

  • Input and maintain data in the Pharmacovigilance (PV) database.
  • Perform initial assessments of Individual Case Safety Reports (ICSRs), if applicable.
  • Evaluate expedited reporting requirements to Health Authorities or client partners, ensuring compliance with reporting timelines.
  • Prepare standard reporting forms (e.g., CIOMS I, MedWatch Forms, XML files).
  • Draft and dispatch follow-up requests for additional information.
  • Submit ICSRs to relevant Health Authorities and client partners.
  • Ensure case processing is completed and documented accurately.
  • Conduct quality checks on ICSRs for accuracy and completeness.
  • Retrieve and assess ICSRs from the EVWEB database and perform company/non-company case classifications.
  • Allocate and manage case workload efficiently.
  • Train team members on system functionalities and best practices.
  • Take on additional responsibilities as directed by the management team.

Why Join PharmaLex?

At PharmaLex, we offer:

  • A collaborative and forward-thinking work environment.
  • Opportunities to grow professionally and build your expertise.
  • Involvement in impactful projects that contribute to the healthcare industry.

How to Apply

If you’re ready to be part of our innovative and growing team, please submit your application online, including:

  • Your earliest possible start date
  • Visa requirements, if applicable
  • Salary expectations

Contact:
Ms. Chhabra
Specialist, Human Resources


Note: Applications from agencies will only be considered with prior agreement for this specific job opportunity.


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