Job Title: Specialist – Pharmacovigilance, ICSR
Location: Hyderabad, Telangana, India
Requisition Number: R-045354
Work Pattern: Hybrid
Department: Product Safety / Pharmacovigilance
Category: Experienced Scientist – Pharmacovigilance
At Johnson & Johnson, we believe health is everything. Our expertise in innovative medicines and MedTech enables us to prevent, treat, and cure complex diseases with smarter, less invasive, and personalized healthcare solutions. We are committed to transforming patient outcomes through scientific innovation and cutting-edge technology. Learn more at www.jnj.com.
The Specialist – Pharmacovigilance, ICSR is a pivotal member of our global pharmacovigilance team, driving innovations in case management through data-driven, automated, and AI-enabled solutions. This role combines scientific knowledge with operational excellence to ensure compliance, data quality, and efficiency across the ICSR lifecycle.
This position is based in Hyderabad, India, with a hybrid work model.
ICSR & Pharmacovigilance Leadership:
Lead the design, deployment, and continuous improvement of ICSR capabilities, automation solutions, and AI-driven tools.
Ensure operational readiness and compliance in collaboration with Case Management and cross-functional teams.
Apply pharmacovigilance expertise to evaluate data accuracy, process alignment, and regulatory adherence.
Process & Quality Management:
Identify gaps in systems or workflows, propose corrective actions, and implement sustainable improvements.
Support core case management operations, providing validation for protocol-linked activities.
Design and execute structured case-testing scenarios, including realistic ICSR cases, test scripts, and validation steps to ensure end-to-end process integrity.
Governance & Stakeholder Engagement:
Drive governance frameworks, training programs, and performance monitoring to maintain inspection-ready systems.
Collaborate across sites, regions, and functions to ensure smooth adoption and operational excellence of new capabilities.
Behavioral Competencies:
Proactive, independent, and solution-oriented mindset with the ability to navigate ambiguity.
Strong collaboration, communication, and problem-solving skills across cross-regional teams.
Commitment to quality, compliance, and shared team success.
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, Nursing, or related field.
5–8 years of experience in pharmacovigilance, case management, or regulated operations.
Deep understanding of the ICSR lifecycle (intake, processing, reporting) and pharmacovigilance principles (seriousness, causality, expectedness, MedDRA).
Experience in process improvement, automation, or AI-enabled workflow optimization in regulated environments.
Proven skills in designing and executing test scripts or case-testing scenarios for system validation and data accuracy.
Strong analytical, communication, and collaboration skills.
Fluency in English (written and spoken).
Preferred Qualifications:
Experience with safety systems such as ArisGlobal LifeSphere, Oracle Argus, or similar.
Familiarity with automation, AI/GenAI, and process innovation.
Understanding of metrics, KPIs, and continuous improvement methodologies.
Ability to work effectively in a dynamic, evolving environment.
Analytical Reasoning & Clinical Operations
Cross-Functional Collaboration & Coaching
Quality Control (QC) & Quality Management Systems (QMS)
Regulatory Affairs Management & Safety Investigations
Serious Adverse Event Reporting & Root Cause Analysis (RCA)
Technologically Savvy, Detail-Oriented, Safety-Oriented
Apply Now to join a global pharmacovigilance team in Hyderabad and contribute to innovative, patient-centric solutions that shape the future of healthcare.
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Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
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Rangpo |Tamil Nadu :
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Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Albama :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |Arkansas :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |New Mexico :
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China | Quarry Bay |Hubei :
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Remote - South America (Latin Americal) | Zaragoza | Ireland | Faridabad | Nairobi | Belgium | Lousiana | Melbourne | Hungary | Hammond | Remote | Manipal | Riga | Thailand | Leinster | Slovakia | Castlebar | Blue Bell | Xzagreb | Remote, USA | Victoria | Remote - Europe | Green Way | Tulsa | Remote - Africa | Medan | Bountiful | Lenexa | French | Springville | Switzerland | Texas | McFarland | Remote - Middle East | Minnesota | Bishop |Bucharest :
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Rabigh | Jeddah | Najran | Riyadh | Khulais | King Abdullah Economic City |Nišava District :
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