Specialist, Pharmacovigilance – ICSR
Location: Hyderabad, India
Category: Pharmacovigilance / Product Safety
Employment Type: Hybrid Work
Company: Johnson & Johnson
Requisition ID: R-045354
About the Role
Johnson & Johnson is seeking a Specialist, Pharmacovigilance, ICSR to support advancements in global Individual Case Safety Report (ICSR) capabilities. This role focuses on enhancing system performance, improving process compliance, implementing innovative technologies, and strengthening data integrity within Global Case Management.
The position requires strong pharmacovigilance expertise, operational understanding of case processing workflows, and experience with digital and automation-driven solutions in a regulated environment.
Key Responsibilities
ICSR Capability Development
Lead the design, deployment, and continuous improvement of ICSR capabilities, including automation tools, AI-supported solutions, and data-driven workflows.
Collaborate with Global Case Management and cross-functional teams to ensure compliant integration and operational readiness of new systems.
Establish governance frameworks, training modules, and performance-monitoring processes to maintain inspection readiness and system reliability.
Operational Excellence and Compliance
Apply pharmacovigilance knowledge to assess data accuracy, process adherence, and system behavior.
Identify operational gaps, recommend corrective and preventive actions, and support long-term compliance improvements.
Support case-management activities by validating protocol requirements, capability-linked processes, and workflow readiness.
Testing and Validation
Develop and execute structured case-testing scenarios, including realistic ICSR case creation, test script writing, validation steps, and documentation.
Ensure robust verification of system functionality, data integrity, and alignment with end-to-end case-processing workflows.
Behavioral Competencies
Ability to work independently in a remote, cross-regional environment.
Strong problem-solving and analytical skills with sound judgment.
Effective communication and collaborative working style across global teams.
High level of professionalism, accountability, and commitment to quality.
Adaptability and resilience in dynamic operational environments.
Required Qualifications
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, Nursing, or a related discipline.
5–8 years of experience in pharmacovigilance, ICSR case management, or regulated safety operations.
Deep understanding of the ICSR lifecycle, including intake, triage, processing, QC, and reporting.
Strong knowledge of PV principles including seriousness, causality, expectedness, and MedDRA terminology.
Experience in AI or automation-driven process improvements within safety operations.
Proven experience designing and executing test scripts and case-testing scenarios for system validation.
Excellent analytical, communication, and stakeholder collaboration skills.
Fluency in written and spoken English.
Preferred Qualifications
Experience with safety databases such as ArisGlobal LifeSphere, Oracle Argus, or comparable systems.
Familiarity with automation platforms, digital innovation, and GenAI-supported workflows.
Understanding of safety metrics, KPIs, and continuous improvement methodologies.
Ability to work effectively in fast-paced and evolving regulatory environments.
Required Skills
Analytical reasoning, detail orientation, cross-functional collaboration, pharmacovigilance case processing, quality control, quality management systems, regulatory understanding, report writing, root cause analysis, safety investigations, serious adverse event reporting, technology proficiency.
Preferred Skills
Clinical operations insight, coaching ability, workflow optimization, safety system expertise, and continuous-improvement mindset.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Kakinada | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Delhi | India | New Delhi | PAN-India |Assam :
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Digha | Kolkata | Mukundapur |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Goa :
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Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Abilene | Arlington | Austin | Boerne | Brenham | Bulverde | Carrollton | Cedar Hill | Corpus Christi | Corsicana | Dallas | Denton | El Paso | Fort Worth | Garland | Houston | Lakeway | Longview | Mcallen | North Richland Hills | Plano | Richardson | San Antonio | Seguin | Tyler | Waco |California :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
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McFarland | Green Way | Springville | Nairobi | Remote - South America (Latin Americal) | French | Melbourne | Remote, USA | Zaragoza | Medan | Lenexa | Switzerland | Remote - Africa | Bountiful | Remote | Castlebar | Leinster | Bishop | Lousiana | Thailand | Regulatory Labeling Manager (NA and LATAM Only) | Hungary | Texas | Riga | Faridabad | Remote - Europe | Belgium | Tulsa | Minnesota | Ireland | Remote - Middle East | Hammond | Manipal | Slovakia | Victoria | Blue Bell | Xzagreb |Republic of Colombia :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
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Prague |Chile :
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