Job Overview

Job Title: Pharmacovigilance Systems Support

Location: India
Job Type: Permanent

Main Responsibilities:

• Incident Resolution and Escalation: Accountable for resolving and escalating incidents in LSMV, LSR, and other Pharmacovigilance (PV) tools, managing user requests in collaboration with Digital teams and PV Database hosting vendors.

• Stakeholder Collaboration: Participate in discussions with PV business stakeholders to understand business requirements, document user needs, and ensure they are included in the Prioritization List and addressed with the Vendor & Digital teams.

• Communication: Communicate important messages to all stakeholders and users, including system releases, issues, downtimes, and updates.

• User Acceptance Testing (UAT): Perform UAT for system upgrades or enhancements and ensure all releases meet GxP validation requirements.

• Release Management: Plan and execute test scripts for scheduled and ad-hoc releases, ensuring smooth implementation in collaboration with Vendor/Digital teams.

• Training & Support: Participate in updating training materials and facilitate support and training sessions for system users. Maintain systems access and assess any impact on security due to new features.

• Audit/Inspection Readiness: Support Audit/Assessment/Inspection readiness and lead or participate in system internal audits or external inspections as needed.

• Incident Management: Work alongside Digital & Vendor teams to assist with incidents and escalations as part of governance structure.

• Safety Reporting: Work with the Safety Team to provide safety data and ad-hoc reports on an urgent basis.

• Configuration Changes: Support vendor teams in configuration changes, testing, and deployments. Understand PV configuration standards, distribution rules, and study configurations.

• Agile Environment: Work in an Agile environment to meet evolving business needs.

Required Experience & Knowledge:

• Pharmacovigilance Systems Experience: Experience with PV databases like ARGUS, Aris-G, VAULT Safety, LSMV, etc.

• Systems Operations Support Role: Experience as a business analyst, configuration manager, or business relationship manager in safety/pharmacovigilance.

• Safety Systems Knowledge: Experience with leading safety systems and understanding the safety/pharmacovigilance process and regulations (ICH GVP, GxP).

• Regulatory Compliance: Knowledge of regulatory requirements for safety reporting (e.g., CIOMS forms, EudraVigilance, FDA REMS) and ensuring compliance with these standards.

• IT Systems Knowledge: Understanding of IT systems in the pharmaceutical industry with an emphasis on PV systems and validation processes.

• Database Skills: Knowledge of SQL, PL/SQL, and Microsoft Office (especially Excel, Word, and PowerPoint).

• GxP Systems Experience: Minimum 6-8 years of pharmaceutical industry experience, especially in GxP systems and pharmacovigilance databases.

• Process Improvement: Experience with process improvement practices in safety or pharmacovigilance systems.

Soft Skills:

• Stakeholder Management: Strong negotiation, communication, and interpersonal skills.

• Analytical Skills: Proactive with effective problem-solving abilities and attention to detail.

• Project Management: Excellent organizational and project management skills, able to work cross-functionally and effectively in global environments.

• Team Leadership: Ability to think strategically, lead teams, and collaborate effectively with cross-functional departments.

• Cross-functional Collaboration: Strong communication skills to work with teams in different functions (e.g., clinical, medical affairs, regulatory).

• Presentation Skills: Ability to present findings and recommendations clearly to mid-level management, stakeholders, or regulatory bodies.

Technical Skills:

• Safety Database Management: Familiarity with safety databases (e.g., Aris-G, LSMV, Argus Safety, VigiBase) for collecting, analyzing, and reporting adverse event data.

• Business Intelligence Tools: Experience with tools like Power BI or Spotfire to create visual reports and dashboards.

• Software Testing & Validation: Knowledge of user acceptance testing (UAT) for pharmacovigilance software, data migration processes, and system upgrades.

• Cross-Department Communication: Ability to communicate data insights and recommendations effectively to various departments.

Education:

• Scientific Background: Bachelor’s degree in Pharmacy, Life Sciences, Engineering, or equivalent academic qualifications is desirable.

• Languages: Fluent in English.

Let me know if you'd like any further adjustments!

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