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)

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