Senior Safety Analyst

At Johnson Johnson we believe health is everything Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented treated and cured where treatments are smarter and less invasive and solutions are personal Through our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity Learn more at https www jnj com Job Function Product Safety Job Sub Function Drug Product Safety Operations Job Category Professional All Job Posting Locations Bangalore Karnataka India Hyderabad Andhra Pradesh India Mumbai Maharashtra India The Safety Data Analytics SDA Sr Analyst will bring experience in data retrieval and report development strategy This individual will manage coordinate and fulfil various sophisticated requests collaborating with programmers on investigations and query builds supporting health authority QPPV inspections audits legal ad hoc requests etc They will transcribe business requests into technical requirements confirming safety data output is fit for purpose and is aligned with team guidelines and procedures ensuring data standards are met They will provide support and maintain close collaboration with cross-functional safety partners to ensure requested results are delivered in accordance with developed standards and customer expectations Moreover they will actively participate in cross-functional projects and opportunities on behalf of the SDA team The SDA Sr Analyst will have advanced relational database Pharmacovigilance systems and processes knowledge including understanding of GxP Operating with a high level of independence they will consistently deliver high-quality results Principal responsibilities include Support Daily Operations Assist in executing daily operational activities within the SDA group to enhance efficiency and effectiveness Customer Collaboration Work closely with stakeholders ensuring seamless communication and operational support Stakeholder Communication Communicate effectively with stakeholders regarding data quality expectations and findings to foster accountability and trust Continuity of Coverage Contribute to the maintenance of coverage for QPPV requirements to acquire data from the Global Safety Database at any given time Facilitate Team Collaboration Promote a collaborative environment that encourages problem-solving and effective decision-making across the global team Report Investigations Support the investigation of Pharmacovigilance PV reports collaborating with SDA programmers IT vendors and other stakeholders Training and Mentorship Provide guidance and support to team members on best practices for maintaining high-quality data standards Health Authority Support Provide assistance during health authority interactions including inspections ensuring all relevant information is readily available Maintain Compliance Adhere to regulatory and compliance standards in data handling and reporting ensuring all outputs align with industry best practices Initiative Participation Engage in departmental and cross-functional initiatives contributing insights and analytical support to drive success Documentation Excellence Maintain thorough documentation of data methodologies and processes to ensure transparency and reproducibility of analyses Issue Reporting Identify and communicate issues to leadership to ensure timely resolution and support smooth operations Innovative Project Contribution Support novel projects by contributing ideas and analytical expertise driving enhancements even in the absence of defined processes Collaboration on SDA Activities Work in partnership with both internal and external entities on SDA-related activities fostering strong relationships and effective communication Data Validation Techniques Use advanced data validation techniques to assess the accuracy completeness and consistency of data sets before analysis Professional Development Engagement Participate in ongoing professional development activities and complete additional deliverables as required Continuous Improvement Actively participate in initiatives aimed at improving data quality and reporting processes contributing insights and suggestions for enhancements Minimum Qualification Bachelors degree computer science data science life science or related field Previous pharmaceutical industry experience typically demonstrated by a minimum of 3-5 years of pharmaceutical experience Demonstrable understanding of relational databases required Solid understanding of Pharmacovigilance regulatory framework e g GxP ICH Solid grasp of Adverse Event processing Working knowledge of Pharmacovigilance systems and understanding of processes supported required Demonstrated strong analytical skills and effective time management abilities Proven track record of optimizing workflow processes evaluating and enhancing operational efficiency quality and compliance in a dynamic agile environment Other requirements Strong computer proficiency e g MS Office Strong verbal and written communication skills required Strong presentation skills to fit target audience Ability to work independently to investigate and resolve technical or data issues with attention to detail is required Strong analytical skill Extensive knowledge of the safety database and business intelligence tools to provision safety data Demonstrated ability to work autonomously with minimal supervision effectively managing tight deadlines while maintaining a positive attitude and a strategic outlook