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
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 :
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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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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro | White Plains |Texas :
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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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Bangor | Brewer |New Jersey :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Tallinn |Hà Nội :
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Bangkok |Israel :
Tel Aviv | Yavne | Netanya | Kfar Saba | Be'Er Sheva |Remote :
Springville | Belgium | Xzagreb | Slovakia | Bountiful | Regulatory Labeling Manager (NA and LATAM Only) | Bishop | Castlebar | Lenexa | Leinster | Nairobi | Riga | McFarland | Remote - Europe | Lousiana | Ireland | Green Way | Texas | Faridabad | Blue Bell | Remote, USA | Switzerland | Manipal | Medan | Tulsa | French | Victoria | Zaragoza | Remote - South America (Latin Americal) | Minnesota | Hungary | Remote - Africa | Melbourne | Remote - Middle East | Thailand | Remote | Hammond |Republic of Colombia :
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Kyiv |Lima Region :
Lima |France :
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Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
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Sofia |Sweden :
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