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Sr. Specialist, Case Processor

0-2 years
Not Disclosed
10 Dec. 24, 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 Title: Pharmacovigilance Specialist

Location: Remote/Office-based
Reporting to: Management Team
Department: Pharmacovigilance


Key Responsibilities:

  1. Data Management:

    • Data entry of Individual Case Safety Reports (ICSRs) into the pharmacovigilance database.
    • Perform the initial assessment of ICSRs, as applicable.
  2. Regulatory Reporting:

    • Evaluate the need for expedited reporting to Health Authorities and partners of the client, including determination of reporting timelines.
    • Prepare standard reporting forms such as CIOMS I, MedWatch Forms, and XML files.
    • Submit ICSRs to relevant Health Authorities and client partners.
  3. Follow-Up Coordination:

    • Prepare and send follow-up requests to gather additional safety information when required.
  4. Case Management:

    • Complete, document, and manage cases in adherence to company and regulatory standards.
    • Retrieve ICSRs from EVWEB databases and perform company/non-company assessments.
    • Allocate and manage cases to ensure timely processing and compliance.
  5. Quality Assurance:

    • Perform quality checks on ICSRs to ensure accuracy and completeness.
  6. Training and Support:

    • Provide training on the pharmacovigilance system to team members.
  7. Additional Duties:

    • Assist in other responsibilities and tasks as assigned by the Management team.

Required Qualifications & Skills:

  • Educational Background:

    • Degree in a relevant field such as Pharmacy, Life Sciences, or equivalent.
  • Experience:

    • Prior experience in pharmacovigilance, particularly in ICSR processing and database management, is an advantage.
  • Technical Skills:

    • Familiarity with pharmacovigilance databases (e.g., Argus, ARISg, or EVWEB).
    • Knowledge of regulatory requirements for safety reporting (e.g., EMA, FDA).
  • Soft Skills:

    • Strong attention to detail and analytical skills.
    • Excellent organizational and time management abilities.
    • Effective communication and collaboration skills for cross-functional teamwork.
  • Language:

    • Proficiency in English is required. Additional languages are a plus.

Other Details:

  • Start Date:

    • Please indicate your earliest possible starting date in your application.
  • Visa Requirements:

    • Mention any visa requirements in your application.
  • Salary Expectations:

    • State your expected salary range in your application.

Interested in joining our dynamic Pharmalex team?

Apply online by submitting your application documents, including your CV, earliest starting date, visa requirements (if applicable), and salary expectations.

For further information, please feel free to contact:

Ms. Chhabra
Specialist, Human Resources


Note: Agencies are requested to contact only by prior agreement for this specific job opportunity.