Pharmacovigilance Report Analyst

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)

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