Pharmacovigilance System Analyst

Main responsibilities:

• This position is Accountable for resolving and escalating incidents in LSMV, LSR & other PV tools, managing user requests in collaboration with Digital teams and PV Database hosting Vendor

• Participate in discussions with PV business stakeholders to understand business requirements, document user requirements and ensure these are included on the Prioritization List and addressed in collaboration with Vendor & Digital teams

• Communicate important messages relevant to all levels of stakeholders & users, including content and plan of systems releases, issues, downtimes, etc.

• Perform User Acceptance Testing for system upgrades or enhancements

• Plan for scheduled/ad-hoc releases by developing and execution of test scripts. Work in close collaboration with Vendor/Digital teams for the implementation of all releases in ensuring GxP validation requirements are met

• Participate in updating training materials as releases move through the development and deployment process. Facilitate support and training sessions for system users

• Maintain systems access and assessing any impact to systems security due to the introduction of new system features. 

• Conduct regular access management reviews to remain in compliance with corporate security policies

• Responsible for supporting Audit/Assessment/Inspection readiness and lead or participate in system internal audits and/or external inspections as needed

• Work alongside digital & vendor assigned staff to assist with incidents and escalations as needed as part of governance structure

• Work with Safety Team during Audits & Inspections for providing Safety Data and Ad-hoc reports on urgency basis

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

• Support vendor teams in Configuration Changes needs, Testing & Deployments

• Work with Business Users to understand the Configuration change needs and document them

• Understand the PV Configuration Standards, Distribution Rules, Study Configurations

• Work in an Agile environment

About you

Experience:

·Experience in PV Databases like ARGUS, Aris-G, VAULT Safety, LSMV etc.

·Experience in a systems operations support role within safety/pharmacovigilance as business analyst, configuration manager or business relationship manager

·Experience with leading safety systems

·Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GVP 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 SQL, PL/SQL and 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