Instagram
youtube
Facebook

Quality Review & Regulatory Report Submission

5-6 years
Not Disclosed
10 Dec. 11, 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 Title: Pharmacovigilance (PV) Regulatory Report Specialist

Key Responsibilities:

  • Approve and schedule reports in the Argus database for submission to the respective health authorities as applicable.
  • Submit cases to health authorities, business partners, and affiliates as required.
  • Ensure adherence to internal and external timelines for case processing to maintain regulatory reporting compliance.
  • Schedule and approve regulatory reports based on reporting obligations.

Job Requirements:

  • Years of Experience: 4-6 years of relevant experience in Pharmacovigilance (PV), with a focus on ICSR Quality Review and Regulatory Report Submissions. Hands-on experience with the Argus Database is essential.
  • Educational Qualification: B.Pharm, M.Pharm.

Skills and Competencies:

  • Strong knowledge of pharmacovigilance regulations and guidelines for health authority submissions.
  • Expertise in quality assurance and compliance.
  • Excellent attention to detail and analytical skills.
  • Effective communication and time management abilities.