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Manager, Pharmacovigilance

10+ years
Not Disclosed
10 Jan. 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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: Manager, Pharmacovigilance
Location: Bengaluru/Hyderabad
Company: ClinChoice Inc.
Experience: 10+ years of relevant experience


Job Overview

ClinChoice Inc. is seeking a highly skilled Manager in Pharmacovigilance with over 10 years of experience to join their team. The ideal candidate will have extensive knowledge of ICH-GCP, relevant GVP modules, 21 CFR guidelines, and other regulatory requirements. This role involves managing high ICSR volumes, handling fluctuations, and processing serious and non-serious ICSRs across various sources, including spontaneous, literature, regulatory authorities, solicited, and clinical trials.


Key Responsibilities

  • Regulatory Compliance: Ensure thorough knowledge and adherence to ICH-GCP, GVP modules, 21 CFR guidelines, and other regulatory requirements.
  • Team Management: Manage a team, oversee project management, and provide client-facing support.
  • ICSR Management: Process serious, non-serious, and potentially serious ICSRs from multiple sources.
  • Training and Mentoring: Provide training and mentoring on ICSR processing, GVP modules, and MedDRA.
  • Oncology & Rare Disease Expertise: Experience in rare disease and oncology pharmacovigilance.
  • Literature Review: Experience in literature review will be a value-add.
  • MS Office Proficiency: Must be proficient in MS Office applications for documentation and reporting.

Required Skills & Experience

  • Experience: 10+ years of relevant pharmacovigilance experience.
  • Knowledge: Strong knowledge of ICH-GCP, GVP modules, 21 CFR guidelines, and regulatory requirements.
  • ICSR Management: Hands-on experience in processing and managing ICSRs, especially in high volume and fluctuating environments.
  • Training & Mentoring: Strong training, mentoring, and management skills for ICSR and MedDRA.
  • Specialization: Experience in rare diseases and oncology preferred.
  • Literature Review: Experience in literature review would be advantageous.
  • Proficiency: Hands-on experience with MS Office applications (Word, Excel, PowerPoint).

How to Apply

If you meet the required qualifications and are eager to contribute to the team, please send your updated resume to megha.chinnappa@clinchoice.com.