Associate Pharmacovigilance, ICSR

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Job Function:

Product Safety

Job Sub Function:

Pharmacovigilance

Job Category:

Scientific/Technology

All Job Posting Locations:

Hyderabad, Andhra Pradesh, India

Job Description:

Job Title: Associate Pharmacovigilance, ICSR

About the Role

Join a global pharmacovigilance team transforming case management through smarter, data-driven solutions. The Associate Pharmacovigilance, ICSR Capabilities, helps design, implement, and sustain innovative process and technology improvements across Global Case Management. This position combines scientific and operational expertise to enhance efficiency, compliance, and data quality in patient safety reporting.

Key Responsibilities

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

• Collaborate with Case Management and cross-functional partners to ensure operational readiness, adoption, and compliant integration of new capabilities.

• Drive governance, training, and performance monitoring frameworks that keep capabilities reliable, effective, and inspection-ready.

• Apply pharmacovigilance expertise to evaluate data accuracy and process alignment

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

• Support core case-management operations by providing input and validation for protocol-related or capability-linked activities, ensuring operational readiness and compliance.

• Design and execute structured case-testing scenarios, including the creation of realistic ICSR case scenarios, detailed test scripts, and validation steps to ensure accurate system behavior, data integrity, and alignment with end-to-end case management processes.

Behavioral Competencies

• Ability to work independently and proactively manage responsibilities in a remote, cross-regional environment.

• Strong problem-solving mindset, with the ability to understand issues, propose solutions, and escalate appropriately.

• Collaborative team spirit, with a genuine commitment to shared success, constructive communication, and respectful partnership with colleagues across sites and time zones.

• High  professionalism, including reliability, accountability, and a consistent focus on quality and compliance.

• Positive, solution-oriented attitude, with the ability to navigate ambiguity and adapt to evolving priorities.

Required Qualifications

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

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

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

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

• Experience designing, writing, and executing test scripts or case-testing scenarios to validate system functionality and data accuracy

• Strong analytical, communication, and collaboration skills.

• Fluency in English (written and spoken).

Preferred Qualifications

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

• Familiarity with automation & innovation, (e.g GenAI)

• Understanding of metrics and continuous-improvement methodologies .

• Proven ability to operate effectively in a dynamic, evolving environment.

Required Skills:

Preferred Skills:

Clinical Operations, Coaching, Critical Thinking, Cross-Functional Collaboration, Health Intelligence, Performance Measurement, Pharmacovigilance, Process Optimization, Quality Control (QC), Quality Management Systems (QMS), Regulatory Affairs Management, Report Writing, Root Cause Analysis (RCA), Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Technologically Savvy

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