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Associate Pharmacovigilance, Icsr

3-5 years
upto 12 LPA
10 Nov. 21, 2025
Job Description
Job Type: Full Time Education: B.Pharm, M.Pharm, Pharm D., BSc., MSc. 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

Associate Pharmacovigilance, ICSR – Johnson & Johnson | Hyderabad, India

Requisition Number: R-045362
Category: Pharmacovigilance / Product Safety
Work Pattern: Hybrid
Experience Required: Fresher

About the Company

Johnson & Johnson is a global leader in healthcare innovation, advancing solutions across Innovative Medicine and MedTech. The organization is committed to transforming how complex diseases are prevented, diagnosed, and treated through next-generation science, technology, and data-driven breakthroughs. Its global safety teams ensure the highest standards of patient protection and regulatory compliance across all markets.


About the Role

The Associate Pharmacovigilance, ICSR position supports the evolution of global case management through modern, technology-enabled safety operations. This role combines scientific understanding with operational execution to strengthen data quality, compliance, and efficiency across Individual Case Safety Report (ICSR) processes.

Freshers with strong academic backgrounds in life sciences or healthcare disciplines and a keen interest in pharmacovigilance are encouraged to apply.


Key Responsibilities

1. ICSR Capability Development and Optimization

  • Support the design, deployment, and enhancement of tools and processes related to ICSR capabilities, including AI-driven and automation-enabled solutions.

  • Collaborate with global case management teams to ensure seamless adoption and compliant integration of new processes.

2. Operational Readiness and Governance

  • Contribute to capability governance, training, documentation, and performance monitoring frameworks.

  • Ensure systems and processes remain inspection-ready, compliant, and aligned with global PV requirements.

3. Data Quality and Compliance Support

  • Apply pharmacovigilance knowledge to assess data accuracy, consistency, and alignment with global safety standards.

  • Identify gaps in workflows, propose corrective measures, and support implementation of sustainable process improvements.

4. Case Testing and Validation

  • Design structured ICSR test scenarios, detailed test scripts, and validation procedures.

  • Conduct end-to-end capability testing to ensure accurate system behavior, data integrity, and operational performance.

5. Cross-Functional Collaboration

  • Work effectively with system owners, process leads, and global stakeholders to support capability deployment.

  • Provide input to case management operations linked to protocols, workflows, and capability enhancements.


Behavioral Competencies

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

  • Strong analytical and problem-solving mindset with attention to accuracy and compliance.

  • Collaborative working style with respect for diverse teams and time zones.

  • Professional reliability, accountability, and commitment to high-quality output.

  • Adaptability to evolving priorities and operational needs.


Required Qualifications

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

  • Strong foundational understanding of pharmacovigilance concepts, including the ICSR lifecycle, seriousness assessment, causality, expectedness, and MedDRA.

  • Knowledge of safety systems or case processing workflows through internships, certifications, or academic exposure (preferred but not mandatory for freshers).

  • Strong writing, communication, and analytical skills.


Preferred Qualifications

  • Familiarity with safety databases such as Argus or ArisGlobal LifeSphere.

  • Exposure to automation, AI, GenAI, or digital process optimization.

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

  • Ability to operate effectively in a dynamic and evolving work environment.


Core Skills

  • Pharmacovigilance

  • Case Management

  • Safety Reporting

  • Data Quality Review

  • Process Optimization

  • Regulatory Understanding

  • Problem Solving

  • Cross-Functional Collaboration

  • Quality Control

  • Documentation and Report Writing