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Senior Associate Pv (Icsr)

3-4 years
Not Disclosed
10 April 17, 2025
Job Description
Job Type: Full Time Education: B.Pharmacy / M.Pharmacy / Pharm.D 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

 

Senior Associate – Pharmacovigilance (ICSR)
Location: Hyderabad, India
Experience Required: 3–4 Years
Qualification: B.Pharmacy / M.Pharmacy / Pharm.D


Position Overview

We are hiring a Senior Associate – Pharmacovigilance (ICSR) with hands-on experience in ICSR case processing and a strong understanding of global safety reporting requirements. The ideal candidate will contribute to drug safety operations, literature screening, and timely ICSR submissions in compliance with regulatory standards.


Required Qualifications

  • Bachelor’s or Master’s degree in Pharmacy (B.Pharm/M.Pharm) or Doctor of Pharmacy (Pharm.D)


Preferred Skills & Competencies

  • 3–4 years of proven experience in pharmacovigilance, including:

    • ICSR processing (solicited & unsolicited)

    • Literature-based case identification

    • Aggregate report handling

  • Strong command of:

    • Medical terminology

    • Clinical pharmacology

    • Diagnostic and treatment procedures

    • Pathological investigations

  • Deep understanding of international PV regulations and reporting requirements.

  • Excellent communication skills – both verbal and written in professional English.

  • Strong attention to detail and analytical thinking.

  • Excellent organizational and time management abilities.

  • Capability to work independently and collaboratively within global teams.


Key Responsibilities

  • Perform case processing for ICSRs from various sources (solicited, unsolicited) related to:

    • Drugs

    • Devices

    • Vaccines

    • Biologic products

    • Cosmetics

  • Conduct quality control (QC) review of:

    • Literature searches

    • Individual Case Safety Reports

  • Ensure accurate and timely reporting of ICSRs and other safety deliverables to clients and regulatory authorities.

  • Maintain thorough documentation of ICSR-related activities and literature reviews in compliance with applicable SOPs.

  • Collaborate effectively with internal teams and clients to ensure seamless project execution.

  • Stay updated with evolving pharmacovigilance regulations and industry best practices.