Main responsibilities:

• Participate in Design & Development of the Safety Compliance & Reporting needs

• 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

• Understand the Case Submissions Lateness reasons and propose and implement CAPAs

• 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, PSUR webpage tools

• Support 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

• Participate in Report Automations using Dashboarding & Paginated Reporting tools & techniques

• Actively participate and contribute to the growing needs of Drug Safety Regulations

• Participate in any other assigned activities related to the PV domain

• 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

• Reports 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, NLP modules is preferred

• Experience with development & analysis PV Reporting systems

• Experience in Compliance Monitoring Tools

• Experience with PV Signal Systems

• Experience in handling the ICSR Submission Lateness reasons and CAPAs related to it

• 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 Computer System Validation processes and using ALM

• Good knowledge of MS Office

• Minimum 5 years of pharmaceutical industry experience with a focus on pharmacovigilance reporting

• Strong experience in IS and validation is required

• Incumbent should have experience in Process Improvement practices

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.

• 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:

• Regulatory Standards, Good Pharmacovigilance Practices (GxP), Safety Reporting Requirements.

• 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.

• Software Testing/Validation: Knowledge of user acceptance testing (UAT) for pharmacovigilance software and familiarity with data migration processes during system upgrades

• Report Writing: Ability to write clear, concise, and accurate reports, including regulatory reports, internal analyses, and safety assessments. This includes the ability to translate complex data into understandable narratives.

• Business Intelligence Tools: Experience with tools like Power BI, or Spotfire to create visual reports and dashboards for stakeholders.

Education:

Bachelor’s degree in pharmacy / Life Sciences / Engineering or equivalent Academic qualification is desirable with 5 years’ Technical Experience in GxP systems preferably in PV databases

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 and check out our Diversity Equity and Inclusion actions at sanofi.com!