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Pharmacovigilance Executive

0-2 years
2-3 Lacs P.A.
10 Oct. 30, 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

Position Overview

We are seeking a dedicated professional to join our Cephalosporin & General Medicines Unit. The ideal candidate will have expertise in preparing and reviewing Modules 4 and 5 of the CTD dossier and possess a strong background in pharmacovigilance and clinical research.

Key Responsibilities

  • CTD Dossier Preparation: Update and maintain Module 4 & 5 of the CTD dossier according to country-specific requirements.
  • Regulatory Coordination: Collaborate with Regulatory Affairs (RA) to maintain records of side effects and adverse events.
  • Agency Communication: Respond to queries from various regulatory agencies effectively and accurately.
  • Data Management: Ensure data accuracy and manage scientific databases and search engines proficiently.
  • Documentation Skills: Utilize Microsoft Office (Word, Excel, PowerPoint) for documentation and reporting.

Qualifications

  • Education:
    • UG: B.Pharma in Pharmacy
    • PG: M.Pharma in Pharmacy
  • Experience:
    • Technical knowledge and experience in pharmacovigilance and clinical research.
    • Proven ability to manage scientific data and documentation.

Skills Required

  • Technical Proficiency: Excellent understanding of CTD dossier preparation.
  • Communication: Strong verbal and written communication skills.
  • Motivation: Self-motivated and enthusiastic with a strong focus on accuracy.
  • Flexibility: Willingness to travel and meet with manufacturing plant representatives as required.

Employment Details

  • Role: Pharmaceutical & Biotechnology - Other
  • Industry Type: Pharmaceutical & Life Sciences
  • Department: Research & Development
  • Employment Type: Full Time, Permanent
  • Role Category: Pharmaceutical & Biotechnology

If you meet these qualifications and are ready to contribute to our mission, we encourage you to apply.