Instagram
youtube
Facebook

Pharmacovigilance,Manager

10+ years
Not Disclosed
10 Jan. 28, 2025
Job Description
Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates 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: Manager, Pharmacovigilance
Location: Bengaluru/Hyderabad
Company: ClinChoice Inc.

Job Overview

ClinChoice Inc. is seeking an experienced and motivated Manager, Pharmacovigilance with over 10 years of relevant experience. The role involves overseeing pharmacovigilance operations, ensuring compliance with regulatory guidelines, and managing a team responsible for handling individual case safety reports (ICSRs) in a variety of therapeutic areas.

Key Responsibilities

  • Regulatory Compliance: Ensure adherence to ICH-GCP, relevant GVP (Good Pharmacovigilance Practices) modules, 21 CFR guidelines, and other applicable regulatory requirements.
  • ICSR Management: Oversee the processing of non-serious, serious, and potentially serious Individual Case Safety Reports (ICSR) from various sources including spontaneous reports, literature, regulatory authorities, solicited reports, and clinical trials.
  • Volume Management: Manage high volumes of ICSR and fluctuations in ICSR volume, ensuring timely processing and compliance.
  • Client Interaction: Serve as a primary point of contact for clients, managing relationships and ensuring client needs are met.
  • Team Leadership: Lead and manage the pharmacovigilance team, providing guidance, training, and mentoring on ICSR processing, GVP modules, and MedDRA.
  • Therapeutic Expertise: Specialize in Rare Diseases and Oncology, ensuring that relevant pharmacovigilance practices are followed in these areas.
  • Literature Review: Conduct and review literature as needed, with experience in literature review considered an added advantage.
  • Software Proficiency: Utilize MS Office applications effectively for reporting, data management, and other day-to-day activities.

Qualifications

  • Experience: 10+ years in pharmacovigilance, with a strong background in ICSR management, regulatory compliance, and team leadership.
  • Therapeutic Expertise: Prior experience in Rare Diseases and Oncology is preferred.
  • Skills:
    • In-depth knowledge of ICH-GCP, GVP modules, 21 CFR guidelines, and pharmacovigilance regulations.
    • Strong people management, project management, and client-facing experience.
    • Expertise in training and mentoring teams on ICSR processing, GVP, and MedDRA.
    • Proficiency with MS Office applications.
    • Experience in literature review is a value-add.

How to Apply

If you possess the necessary expertise and are eager to contribute to our team, please share your updated resume to megha.chinnappa@clinchoice.com.