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Associate Pharmacovigilance, Icsr

2-5 years
Not Disclosed
10 Nov. 24, 2025
Job Description
Job Type: Hybrid 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

Associate Pharmacovigilance, ICSR – Hyderabad (Hybrid Work) | Johnson & Johnson

Location: Hyderabad, India
Function: Product Safety
Sub-Function: Pharmacovigilance
Category: Scientist, Pharmacovigilance (ST4 – E24)
Experience Required: 2–5 years
Work Pattern: Hybrid
Requisition Number: R-045362
Date Posted: Nov 20, 2025

About Johnson & Johnson

Johnson & Johnson is a global leader in healthcare innovation, dedicated to improving human health through science, technology, and patient-centric solutions. With expertise across Innovative Medicine and MedTech, the organization develops advanced treatments, preventive strategies, and next-generation medical solutions that create meaningful impact worldwide.


Role Overview: Associate Pharmacovigilance, ICSR

This role offers the opportunity to support global case management initiatives within a progressive pharmacovigilance environment. As an Associate in Pharmacovigilance (ICSR Capabilities), you will contribute to developing and enhancing process and technology solutions that elevate safety data quality, regulatory compliance, and operational efficiency across Global Case Management.


Key Responsibilities

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

  • Collaborate with Global Case Management and cross-functional teams to ensure seamless implementation and operational readiness of new capabilities.

  • Maintain strong governance, training, and performance monitoring systems that ensure compliance and inspection-readiness.

  • Utilize pharmacovigilance expertise to assess data accuracy, process alignment, and compliance with global safety standards.

  • Partner with system and process owners to identify operational gaps and implement corrective and preventive actions (CAPA).

  • Contribute to case management operations by validating protocol-driven or capability-linked activities.

  • Design and execute structured case-testing scenarios including realistic ICSR examples, detailed test scripts, validation steps, and end-to-end system behavior checks.


Behavioral Competencies

  • Ability to work independently in a remote, cross-regional setup.

  • Strong problem-solving and decision-making capability.

  • Collaborative mindset with excellent communication skills across global teams.

  • High level of professionalism, accountability, and quality focus.

  • Adaptability and a positive approach in dynamic or ambiguous environments.


Required Qualifications

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

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

  • Strong understanding of the complete ICSR lifecycle (intake, processing, reporting).

  • Knowledge of key PV concepts: seriousness, causality, expectedness, MedDRA.

  • Experience supporting process improvement, automation, AI initiatives, or workflow optimization in a regulated environment.

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

  • Strong analytical and communication skills.

  • Fluency in written and spoken English.


Preferred Qualifications

  • Experience with safety systems such as ArisGlobal LifeSphere, Oracle Argus, or equivalent.

  • Familiarity with GenAI or automation-driven PV innovations.

  • Understanding of performance metrics, continuous-improvement methodologies, and quality systems.

  • Proven ability to perform effectively in fast-changing environments.


Required & Preferred Skills

Required Skills:
Pharmacovigilance, ICSR Processing, Case Management, Data Accuracy Review, Quality Compliance, Process Evaluation, System Testing, Communication Skills, Analytical Thinking.

Preferred Skills:
Clinical Operations, Coaching, Critical Thinking, Cross-Functional Collaboration, Health Intelligence, Performance Measurement, Process Optimization, Quality Control (QC), Quality Management Systems (QMS), Regulatory Affairs, Report Writing, Root Cause Analysis (RCA), Safety Investigations, Serious Adverse Event (SAE) Reporting, Technology Adaptation.