Pharmacovigilance Reporting and Analytics Specialist
Location: India
Employment Type: Permanent
Posted on: Apr. 24, 2025
Closing on: May. 08, 2025
Main Responsibilities:
Participate in the design and development of safety compliance & reporting needs.
Support digital vendor teams in compliance & safety report development, testing, and deployment.
Use data published across the enterprise to effectively integrate data from various sources while generating reports.
Understand case submission lateness reasons and propose and implement CAPAs (Corrective and Preventive Actions).
Maintain validation of safety reports generated from LSRA.
Implement deployment of safety reports as per business needs.
Provide QPPV office with relevant reports for oversight activities.
Support incident & change management of LSRA, LSSRM, and PSUR webpage tools.
Assist PV Country & Global Teams during audits & inspections by providing safety data and ad-hoc reports on an urgent basis.
Participate in discussions with business stakeholders to understand reporting requirements, document them, and ensure these are included in the Backlog List and addressed in collaboration with vendor & digital teams.
Maintain existing reports periodically and during system upgrades.
Work alongside vendor staff during safety database transitions, assist with incidents and escalations as needed.
Participate in report automation using dashboarding & paginated reporting tools & techniques.
Contribute to the growing needs of drug safety regulations.
Perform other activities related to the PV domain as assigned.
Work in an Agile environment.
About You:
Experience:
Experience in PV databases like ARGUS, Aris-G (LSMV), and Cognos & Power BI reports.
Experience in PV reporting systems operations within safety/pharmacovigilance as a business analyst, configuration manager, or business relationship manager.
Report development experience using Cognos & Power BI.
Programming languages like Python, R, Javascript.
DBMS skills – SQL, PL/SQL, Power BI – DAX.
Development knowledge in AI/ML, LLM, and NLP modules is preferred.
Experience with PV reporting systems development & analysis.
Experience in compliance monitoring tools.
Experience handling ICSR submission lateness reasons and CAPAs.
Understanding of pharmacovigilance process and regulations, ICH GCP, and GxP related to system validation and documentation.
Knowledge of IT systems in the pharmaceutical industry, focusing on PV systems.
Knowledge of computer system validation processes and ALM usage.
Good knowledge of MS Office.
Education:
Bachelor’s degree in Pharmacy, Life Sciences, Engineering, or equivalent academic qualification.
Minimum 5 years of technical experience in GxP systems, preferably in PV databases.
Languages:
Fluent in English (verbal and written).
Soft Skills:
Strong stakeholder management, negotiation, and communication skills.
Ability to operate effectively in a global environment and across-line functions.
Attention to detail, analytic, proactive, and effective problem-solving skills.
Excellent organizational and project management abilities.
Ability to work in cross-functional teams and think strategically.
Technical Skills:
Regulatory Standards, Good Pharmacovigilance Practices (GxP), and Safety Reporting Requirements.
Familiarity with safety databases and systems (e.g., Aris-G / LSMV, Argus Safety, VigiBase).
Experience with user acceptance testing (UAT) and data migration during system upgrades.
Report writing, including regulatory reports, internal analyses, and safety assessments.
Experience with tools like Power BI or Spotfire for creating visual reports and dashboards.
Additional Information:
At Sanofi, we provide equal opportunities to all individuals, regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Join us to chase change, embrace new ideas, and explore opportunities to make miracles happen.
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