Job Title: Pharmacovigilance Report Analyst
Location: India
Job Type: Permanent
Posted on: April 15, 2025
Closing Date: April 29, 2025
Experience Required: 6–8 years
Qualifications: Bachelor's degree in Pharmacy, Life Sciences, Engineering, or equivalent
Languages Required: Fluent in English (verbal and written)
Job Description:
The Pharmacovigilance Report Analyst will lead and participate in safety report design and development activities, ensuring compliance and safety report generation across various systems. The analyst will manage report validation, deployment, and maintenance, support digital teams during testing and deployment phases, and assist with audits and inspections. The role involves collaborating with stakeholders to understand reporting requirements and working in an Agile environment to deliver on business needs.
Key Responsibilities:
Lead and participate in the design and development of safety reports.
Ensure the validation of safety reports generated from LSRA and manage deployments based on business needs.
Collaborate with PV Country & Global Teams during audits, inspections, and ad-hoc report requests.
Assist with incident & change management of safety tools like LSRA, LSSRM, and PSUR webpages.
Maintain and update existing reports, ensuring their relevance during system upgrades.
Work with digital vendor teams on compliance and safety report development, testing, and deployment.
Support the QPPV office with relevant oversight reports.
Participate in Agile work environment and contribute to Drug Safety Regulation needs.
Experience and Skills:
Pharmacovigilance Databases: Experience with systems like ARGUS, Aris-G (LSMV), and Cognos, and generating Power BI reports.
Programming Skills: Proficient in Python, R, and familiar with SQL, PL/SQL, Power BI - DAX.
Safety Reporting: Knowledge of regulatory safety reporting requirements such as CIOMS forms, EudraVigilance, and FDA REMS.
Database Management: Experience managing and analyzing safety data in PV systems.
Technical Skills: Knowledge of AI/ML, LLM, and NLP modules preferred.
Validation: Strong experience with systems validation and documentation in compliance with GxP and ICH GCP.
Soft Skills: Strong communication, stakeholder management, and problem-solving skills. Ability to work effectively in cross-functional and multicultural environments.
Required Qualifications:
Educational Background: Bachelor’s degree in Pharmacy, Life Sciences, Engineering, or equivalent.
Experience: 6–8 years in Pharmacovigilance, PV Reporting Systems, and GxP systems.
Language: Fluent in English (both written and verbal).
About Sanofi:
Sanofi is committed to progress and creating opportunities for extraordinary people to make a difference. The company fosters a diverse and inclusive environment and offers equal opportunities to all employees.
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