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Pharmacovigilance Executive

0-2 years
2-3 Lacs P.A.
10 Oct. 25, 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

Job Overview

We are seeking a dedicated professional for our Cephalosporin & General Medicines Unit. The ideal candidate will possess technical knowledge and experience in preparing modules 4 and 5 of the CTD dossier, along with strong skills in data management and communication.

Key Responsibilities

  • Update modules 4 and 5 of the CTD dossier according to country-specific requirements.
  • Coordinate with Regulatory Affairs (RA) to maintain records of side effects and adverse events.
  • Respond to queries from various regulatory agencies.
  • Proficiently use Microsoft Office Suite (Word, Excel, PowerPoint) for documentation and presentations.
  • Ensure data management practices are adhered to with a focus on accuracy.

Qualifications

Education:

  • UG: B.Pharma in Pharmacy
  • PG: M.Pharma in Pharmacy

Key Skills

  • Technical knowledge and experience in preparing CTD dossiers.
  • Proficiency in scientific databases and search engines.
  • Excellent attention to detail and accuracy.
  • Strong self-motivation and enthusiasm.
  • Exceptional communication skills.
  • Willingness to travel and meet with manufacturing plant representatives as required.

Additional Information

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

Preferred Skills

  • Pharmacovigilance
  • Clinical Research
  • Drug Safety

Join us in advancing the pharmaceutical and biotechnology fields with your expertise!