Senior Safety Analyst - Mumbai, Maharashtra - Johnson & Johnson

Description

Job Function: Product Safety

Safety Data Analytics (SDA) Sr. Analyst

We are looking for an experienced SDA Sr. Analyst to join our team at Johnson & Johnson. The ideal candidate will have a strong background in data retrieval and report development strategy, with the ability to manage, coordinate, and fulfill various sophisticated requests.

The SDA Sr. Analyst will be responsible for transcribing business requests into technical requirements, confirming safety data output is fit for purpose, and ensuring data standards are met. They will also 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.

The successful candidate will have advanced relational database and Pharmacovigilance systems and processes knowledge, including understanding of GxP and Operating System regulations. They will work independently to deliver high-quality results, consistently meeting tight deadlines while maintaining a positive attitude and strategic outlook.

Key Responsibilities:

• Support Daily Operations: Assist in executing daily operational activities within the SDA group to enhance efficiency and effectiveness.
• Cross-Functional Collaboration: Work closely with stakeholders to ensure 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 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, 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.

Requirements:

• Bachelor's degree in 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.
• 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 strategic outlook.