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Officer- Literature Screening

0-4 years
Not Disclosed
10 Jan. 15, 2025
Job Description
Job Type: Full Time Education: B. Pharm/M. Pharm/Pharm D 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: Officer - Literature Screening
Company: Lambda Therapeutic Research
Location: Ahmedabad
Experience Level: 0 - 4 years
Compensation: Not disclosed
Employment Type: Full-Time, Permanent

Job Description:
Lambda Therapeutic Research is looking for an Officer to join their Literature Screening team in the pharmacovigilance domain. The role involves reviewing global scientific and medical literature to ensure compliance with company SOPs and regulatory requirements. The officer will maintain records of literature safety reports, support case processing, and contribute to preparing, revising, and reviewing SOPs and training documents. The position requires attention to detail, data entry, drug coding, and collaboration with the team to address urgent safety issues.

Key Responsibilities:

  • Review global scientific and medical literature as per SOPs, WIs, and regulatory guidelines.
  • Maintain organized records of literature safety reports.
  • Assist in case processing, including data entry, drug coding, MedDRA coding, and narrative writing.
  • Perform duplicate searches and initiate cases in the database.
  • Track cases received from regulatory authorities and conduct weekly reconciliations.
  • Communicate urgent safety issues to the Line Manager and QPPV (Qualified Person for Pharmacovigilance).
  • Prepare and review SOPs, WIs, templates, guides, and training documents.
  • Ensure high standards in internal and external communications.

Preferred Qualifications:

  • Education: B. Pharm, M. Pharm, Pharm D (preferably in Pharmacology).
  • Certifications: Pharmacovigilance Certification Course (preferred).
  • Skills:
    • MedDRA coding
    • Drug safety and monitoring
    • Literature review
    • Case processing
    • Communication and interpersonal skills

Competencies:

  • Accountability
  • Communication
  • Work ethic
  • Initiative
  • Leadership
  • Organizational culture fit

Perks and Benefits:

  • Full-time, permanent position with opportunities for career growth.
  • A chance to work with a global leader in pharmacovigilance solutions.

Company Overview:
Lambda Therapeutic Research specializes in providing end-to-end pharmacovigilance services, ensuring safety and compliance across various therapeutic areas, including clinical trials and medical devices. With a robust framework and advanced technology, they monitor drug safety globally.