Pharmacovigilance Reporting and Analytics Specialist

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)