At Johnson & Johnson, we believe health is everything. Our commitment to healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured. With expertise in Innovative Medicine and MedTech, we are uniquely positioned to deliver smarter, less invasive treatments and personalized healthcare solutions. Learn more about our mission at www.jnj.com.
Job Title: Senior Safety Analyst
Location: Mumbai, Bangalore, Hyderabad
Work Pattern: Hybrid
Requisition Number: R-002134
Date Posted: March 13, 2025
Job Description
As a Senior Safety Analyst, you will play a critical role in evaluating and processing adverse events associated with our products. You will serve as a scientific resource, ensuring efficient and compliant operations while leading data collection initiatives across the organization. Your responsibilities will include:
- Data Retrieval & Analysis: Manage and coordinate sophisticated data requests, collaborating with programmers to build queries supporting health authority, QPPV, inspections, audits, and legal requirements.
- Stakeholder Collaboration: Work closely with cross-functional teams to ensure data outputs meet business needs and regulatory standards.
- Pharmacovigilance Expertise: Investigate and resolve pharmacovigilance (PV) reports, ensuring compliance with GxP and ICH guidelines.
- Operational Support: Assist in daily operations, maintaining continuity of coverage for QPPV requirements and supporting health authority interactions.
- Continuous Improvement: Participate in initiatives to enhance data quality, reporting processes, and operational efficiency.
- Training & Mentorship: Guide team members on best practices for maintaining high-quality data standards.
Key Responsibilities
- Support Daily Operations: Enhance efficiency and effectiveness within the Safety Data Analytics (SDA) group.
- Customer Collaboration: Ensure seamless communication and operational support for stakeholders.
- Data Validation: Use advanced techniques to assess the accuracy, completeness, and consistency of data sets.
- Health Authority Support: Provide assistance during inspections and audits, ensuring all relevant information is readily available.
- Innovative Projects: Contribute to novel projects, driving enhancements in data analytics and reporting.
- Documentation Excellence: Maintain thorough documentation of methodologies and processes for transparency and reproducibility.
Qualifications
- Education: Bachelor’s degree in computer science, data science, life sciences, or a related field.
- Experience: 3-5+ years of pharmaceutical industry experience, with a strong understanding of relational databases and pharmacovigilance systems.
- Regulatory Knowledge: Solid grasp of pharmacovigilance regulatory frameworks, including GxP and ICH guidelines.
- Technical Skills: Proficiency in MS Office, safety databases, and business intelligence tools.
- Soft Skills: Strong analytical, communication, and presentation skills, with the ability to work independently and manage tight deadlines.
Why Join Johnson & Johnson?
- Impactful Work: Contribute to groundbreaking healthcare solutions that improve lives worldwide.
- Professional Growth: Access to ongoing development opportunities and cross-functional projects.
- Collaborative Environment: Work with a global team of experts in a supportive and innovative culture.
- Hybrid Work Model: Enjoy the flexibility of a hybrid work pattern, balancing office and remote work.
