**Main responsibilities:** + Lead & Participate in the Safety Report - Design & Development activities + Support digital vendor teams in Compliance & Safety Reports Development, Testing & Deployments + Use the data published across enterprise for effectively integrating data from various sources while generating Reports + Maintain Validation of Safety reports generated from LSRA + Plan & Prioritize deployment of safety reports as per business needs + Support QPPV office with relevant reports for oversight activities + Support incident & change management of LSRA, LSSRM, PSUR webpage tools + Work with PV Country & Global Teams during Audits & Inspections for providing Safety Data and Ad-hoc reports on urgency basis + Participate in discussions with business stakeholders to understand Reporting requirements, document them and ensure these are included on the Backlog List and addressed in collaboration with Vendor & Digital teams + Maintenance of existing reports on periodic basis and during System Upgrades + Work alongside vendor assigned staff for existing safety database during transition period, assist with incidents and escalations as needed as part of governance structure + Actively participate and contribute to the growing needs of Drug Safety Regulations + Work in an Agile environment **_About you_** **Experience** : _Experience in PV Databases like ARGUS, Aris-G (LSMV) and Cognos & Power BI Reports._ + _Experience in a PV reporting systems operations within safety/pharmacovigilance as business analyst, configuration manager or business relationship manager_ + _Programming languages like – Python, R_ + _DBMS skills – SQL, PL/SQL, Power BI – DAX_ + _Development knowledge in AI/ML, LLM, NLP modules is preferred_ + _Experience with development & analysis PV Reporting systems_ + _Experience and understanding of Pharmacovigilance process and regulations, ICH GCP and GxP regarding systems validation and documentation_ + _Knowledge of IT systems in the pharmaceutical industry with an emphasis on PV systems_ + _Knowledge of validation processes_ + _Good knowledge of MS Office_ + _Minimum_ **_6-8_** _years’ pharmaceutical industry experience, experience in GxP systems preferably in PV databases with a focus on pharmacovigilance_ + _Strong experience in IS and validation is required_ + _Incumbent should have experience in Process Improvement practices_ **_Safety Reporting Requirements:_** _Knowledge of regulatory requirements for safety reporting (e.g., CIOMS forms, EudraVigilance, FDA REMS, etc.) and experience in ensuring compliance with these standards._ **Soft skills** : + _Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions._ + _Attention to details, Analytic, pro-active and effective problem-solving skills. Excellent organizational and project management abilities._ + _Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams._ + _Experience in a CHC product and strategic development environment is essential. Previous experience leading a global organization including management of large multi-country budgets is essential._ + _Excellent team-work and interpersonal skills_ + _Ability to work in cross-functional teams_ + _Excellent oral and written communication skills_ + _Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams._ **Technical skills** : **_Database Management_** _: Familiarity with safety databases and systems (e.g., Aris-G / LSMV, Argus Safety, VigiBase, or similar systems) used for collecting, analyzing, and reporting adverse event data._ **_Microsoft Office Suite_** _: Advanced skills in Excel (for data analysis and reporting), Word (for report writing), and PowerPoint (for presenting findings)._ **_Business Intelligence Tools_** _: Experience with tools like Power BI, or Spotfire to create visual reports and dashboards for stakeholders._ **_Software Testing/Validation_** _: Knowledge of user acceptance testing (UAT) for pharmacovigilance software and familiarity with data migration processes during system upgrades_ **_Presentation Skills_** _: Proficiency in presenting findings to mid-level management, stakeholders, or regulatory bodies in a clear and impactful way_ **_Cross-functional Communication_** _: Ability to collaborate with various departments (e.g., clinical, medical affairs, regulatory) and effectively communicate data insights and recommendations.  _ **Education** : _Scientific background: Bachelor’s degree in pharmacy / Life Sciences / Engineering or equivalent Academic qualification is desirable_ **Languages** : _Fluent in English (verbal and written)_ **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. 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