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Associate Pharmacovigilance, Icsr - Hyderabad

2-5 years
Not Disclosed
10 Nov. 27, 2025
Job Description
Job Type: Full Time Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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

Associate Pharmacovigilance, ICSR – Hyderabad, India

Location: Hyderabad, Andhra Pradesh, India
Job Type: Full-Time / Hybrid Work
Job ID: R-045362
Function: Product Safety
Sub-Function: Pharmacovigilance
Category: Scientist, Pharmacovigilance (ST4 – E24)


About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Leveraging expertise in Innovative Medicine and MedTech, we deliver breakthrough solutions across the full spectrum of healthcare. Our mission is to prevent, treat, and cure complex diseases while ensuring patient-centric, smarter, and less invasive treatments. Learn more at jnj.com.


Position Overview

The Associate Pharmacovigilance, ICSR role is integral to a global PV team focused on transforming case management through data-driven and automated solutions. This position combines scientific knowledge with operational expertise to improve efficiency, compliance, and data quality in patient safety reporting.

This role is ideal for professionals with 2–5 years of pharmacovigilance experience who are looking to contribute to global case management, support innovative processes, and drive high-quality ICSR operations.


Key Responsibilities

  • Support the design, deployment, and continuous improvement of ICSR capabilities, including automation, AI-based, and data-driven solutions.

  • Collaborate with Case Management and cross-functional teams to ensure operational readiness, adoption, and regulatory compliance of new processes and tools.

  • Implement governance, training, and performance monitoring frameworks to ensure inspection-ready operations.

  • Apply pharmacovigilance expertise to evaluate data accuracy, process compliance, and operational alignment.

  • Partner with system and process owners to identify gaps, recommend corrective actions, and implement sustainable improvements.

  • Support protocol-related or capability-linked operations and ensure adherence to SOPs and regulatory guidelines.

  • Design and execute structured case-testing scenarios, including realistic ICSR case scenarios, test scripts, and validation steps to ensure data integrity.


Behavioral Competencies

  • Ability to work independently in a hybrid, cross-regional environment.

  • Strong analytical and problem-solving skills with proactive escalation when required.

  • Collaborative mindset with commitment to shared success and constructive communication across teams.

  • High professionalism, accountability, and focus on quality and compliance.

  • Adaptable, solution-oriented, and able to manage ambiguity and shifting priorities.


Required Qualifications

  • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, Nursing, or related field.

  • 2–5 years of experience in pharmacovigilance, case management, or regulated operations.

  • Deep understanding of the ICSR lifecycle (intake, processing, reporting) and PV concepts including seriousness, causality, expectedness, and MedDRA coding.

  • Experience contributing to process improvements, workflow optimization, or automation initiatives in a regulated environment.

  • Experience designing, writing, and executing test scripts or case-testing scenarios.

  • Strong analytical, collaboration, and communication skills.

  • Fluency in English (written and spoken).


Preferred Qualifications

  • Experience with PV safety systems (e.g., ArisGlobal LifeSphere, Oracle Argus, or similar).

  • Familiarity with automation, AI, and innovation tools (e.g., GenAI).

  • Understanding of metrics, KPIs, and continuous improvement methodologies.

  • Proven ability to operate effectively in dynamic, evolving environments.


Key Skills

Required: Pharmacovigilance, Case Management, Clinical Operations, Quality Control, Regulatory Compliance, Root Cause Analysis, Safety Investigations, Data Accuracy, Report Writing.

Preferred: Process Optimization, Cross-Functional Collaboration, Technologically Savvy, Performance Measurement, Coaching, Health Intelligence.