Cencora is hiring for the position of Senior Specialist, Pharmacovigilance System. The role focuses on ownership and governance of pharmacovigilance platforms, coordination between PV business teams and technical teams, system lifecycle management, regulatory compliance, and adoption of emerging technologies including AI/ML. Pasted markdown

Job Details

The position is listed under APAC > India > Noida, APAC > India > Remote, and Sofia, Bulgaria. Pasted markdown

Position Overview

The Senior Specialist, Pharmacovigilance System serves as the strategic and operational bridge between Pharmacovigilance business/operations teams and the technical organization. The role acts as a system champion, business representative, and end-to-end accountability owner for one or more PV platforms and integrated solutions. Pasted markdown

Key Responsibilities

System Ownership and Governance

• Own PV-related platforms including safety databases, signal management tools, medical information systems, literature monitoring solutions, and reporting platforms.
• Maintain system roadmaps and prioritize enhancements, upgrades, and feature rollouts.
• Manage system lifecycle activities from business requirements and UAT through deployment and retirement.
• Maintain business-owned documentation including BRDs, functional specifications, SOPs, user guides, and validation plans.
• Drive business sign-off and acceptance for system changes and releases. Pasted markdown

Business–IT Liaison

• Coordinate between PV Operations, Medical Affairs, Regulatory, Quality Assurance, and Technical/IT teams.
• Translate business and regulatory requirements into technical requirements.
• Facilitate governance meetings and cross-functional working groups.
• Manage relationships with external system vendors and platform providers.
• Escalate risks, issues, and decisions with clear business impact. Pasted markdown

System Champion and Change Enablement

• Promote PV system best practices and user adoption.
• Lead change management for system rollouts and upgrades.
• Coordinate communication, training, and stakeholder engagement.
• Represent PV systems in cross-functional forums and steering committees.
• Evaluate innovative technologies, including AI/ML-assisted capabilities, with IT. Pasted markdown

Compliance and Quality

• Ensure systems comply with applicable regulatory frameworks including ICH E2B(R3), EMA EVMPD, FDA requirements, and GVP modules.
• Work with Quality Assurance to maintain validated systems according to GAMP 5, 21 CFR Part 11, and EU Annex 11.
• Support audits and regulatory inspections.
• Monitor regulatory changes and identify their impact on PV systems.
• Maintain data integrity, traceability, and audit trail standards. Pasted markdown

Operational Performance

• Define and track system KPIs and performance metrics.
• Implement process improvements at the intersection of business workflows and system capabilities.
• Support business continuity, data recovery, and disaster recovery planning.
• Contribute to PV systems portfolio strategy, including build/buy/partner evaluations and technology investment recommendations. Pasted markdown

Eligibility and Qualifications

Candidates should have:

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Health Informatics, or a related field; Master’s degree preferred.
• 3–5 years of experience in Pharmacovigilance, Drug Safety, or a closely related discipline.
• Experience owning or managing PV systems or technology platforms in a business capacity.
• Strong understanding of the end-to-end life science lifecycle, from case intake through aggregate reporting and signal management.
• Experience working in a regulated GxP environment and with validated systems. Pasted markdown

The JD also lists bachelor’s-level backgrounds in medicine, public health, epidemiology, regulatory affairs, or related fields, or equivalent experience, along with 4+ years of experience in pharmacovigilance, drug safety, epidemiology, risk management, scientific consulting, regulatory affairs, or related fields. Certifications in pharmacovigilance, drug safety, regulatory affairs, clinical safety, quality management, or auditing are preferred where applicable. Pasted markdown

Required Skills

Business and Stakeholder Skills

• Cross-functional communication
• Project and program management
• Stakeholder influence
• Analytical and critical thinking
• Requirements gathering
• Business process mapping
• Gap analysis
• Vendor management and negotiation
• Senior leadership engagement Pasted markdown

Pharmacovigilance Technical Knowledge

• Safety databases and case management
• E2B(R3) case data structure
• ICSR processing workflows
• MedDRA coding
• Regulatory submission timelines
• PV reporting platforms and dashboards
• Power BI or equivalent BI tools
• CIOMS and PSUR/PBRER report generation workflows
• Signal management platforms
• Disproportionality analysis including PRR, ROR, and EBGM
• EudraVigilance and FDA FAERS database structures
• Systematic literature search tools
• ICSR extraction and deduplication Pasted markdown

AI, Data and Integration Knowledge

The role requires awareness of AI/ML applications in pharmacovigilance, including AI-assisted case narrative generation, MedDRA auto-coding, NLP for literature monitoring and social media surveillance, predictive analytics for signal detection and risk assessment, and LLMs in PV workflows. Pasted markdown

Additional knowledge includes:

• PV data flows and system integrations
• CRO feeds and affiliate submissions
• E2B gateway connections
• HL7, FHIR, and E2B XML
• Data mapping and data quality principles
• API-based integrations and middleware concepts Pasted markdown

Regulatory and Quality Knowledge

• GVP Modules I, V, VI, VIII, IX, and XVI
• GAMP 5
• 21 CFR Part 11
• EU Annex 11
• CSV/CSA principles
• ICH E2A, E2B, E2C, E2D, and E2E
• Audit trail requirements
• ALCOA+ data integrity standards
• Inspection readiness Pasted markdown

Application Details

Application Link