Senior Specialist, Pharmacovigilance System

PharmaLex India Private Limited; Dadri; Hybrid; INR 1,500,000 - 2,100,000; Full time

Job summary

Cencora is seeking a Senior Specialist, Pharmacovigilance System to bridge PV operations with IT, owning PV platforms end-to-end. You will ensure regulatory compliance, drive lifecycle activities, and champion system change across stakeholders.

The role requires PV domain expertise, strong communication, and a proactive, autonomous mindset to advance technology-enabled safety workflows.

Qualifications

• Bachelor's degree in life sciences, pharmacy, nursing, health informatics, or related field; Master's preferred.
• 3–5 years of experience in pharmacovigilance, drug safety, or closely related discipline.
• Demonstrated experience owning or managing PV systems or technology platforms in a business capacity.
• Strong understanding of end-to-end life science lifecycle from case intake to signal management.

Responsibilities

• System Ownership: act as accountable business system owner for PV platforms; maintain system roadmap and lifecycle activities.
• Business–IT liaison: translate regulatory needs into technical requirements; manage cross-functional forums and vendor relationships.
• System Champion: promote best practices, lead change management, adopt AI/ML capabilities in PV ecosystem.
• Regulatory & Quality: ensure systems comply with GVP, GAMP 5, 21 CFR Part 11, EU Annex 11; support audits and inspections.
• Operations: define KPIs, drive improvements, and support continuity planning.

Skills

Cross-functional communication

Project management

Influence without authority

Analytical thinking

Requirements gathering

Vendor management

Stakeholder engagement

Education

Bachelor's degree (Life Sciences / Pharmacy / Nursing / Health Informatics)

Master's degree preferred

Tools

PV databases

Power BI

E2B XML

HL7/FHIR

Job description

Job Details

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere.

The Senior Specialist, Pharmacovigilance System serves as the strategic and operational bridge between the Pharmacovigilance (PV) business/operations teams and the technical organization. This individual acts as the system champion, business representative, and end-to-end accountability owner for one or more pharmacovigilance platforms and integrated solutions — ensuring these systems meet regulatory, operational, and quality standards throughout their lifecycle. This is a highly cross-functional role that requires a unique blend of deep PV domain expertise, systems thinking, stakeholder management, and a forward-looking understanding of emerging technologies including AI. This person ensures those technical workstreams are effectively directed and aligned to business needs.

Key Responsibilities

• System Ownership and Governance
  Serve as the accountable business system owner for PV-related platforms, including safety databases, signal management tools, medical information systems, literature monitoring solutions, and reporting platforms
  Own and maintain the system roadmap, prioritizing enhancements, upgrades, and new feature rollouts in alignment with business strategy and regulatory requirements
  Lead and manage system lifecycle activities — from business requirements definition, UAT, deployment, through to retirement — ensuring timely and quality delivery of all system milestones
  Maintain and govern all business-owned system documentation, including Business Requirements Documents (BRDs), functional specifications, SOPs, user guides, and validation plans (in close collaboration with validation/QA teams)
  Drive business sign-off and acceptance for all system changes, releases, and validation activities
• Business–IT Liaison and Stakeholder Management
  Act as the primary point of contact for all system-related matters between PV Operations, Medical Affairs, Regulatory, Quality Assurance, and the Technical/IT organization
  Translate complex business and regulatory needs into clear, actionable technical requirements for IT developers and vendors
  Facilitate regular forums, governance meetings, and working groups to ensure alignment across business and technical stakeholders
  Manage relationships with external system vendors and platform providers, including participating in vendor performance reviews, roadmap discussions, and contract input where applicable
  Escalate risks, issues, and decisions through appropriate channels with clear business impact framing
• System Champion and Change Enablement
  Serve as the internal ambassador for PV systems — promoting best practices, driving adoption, and advocating for user-centric design
  Lead change management efforts for system rollouts and upgrades, including communication planning, training coordination, and stakeholder engagement
  Represent the PV systems landscape in cross-functional forums, steering committees, and process improvement initiatives
  Champion the adoption of innovative technologies — including AI/ML-assisted capabilities — within the PV ecosystem, evaluating feasibility and business value in partnership with IT
• Compliance, Quality & Regulatory Alignment
  Ensure all systems under ownership comply with applicable global regulatory frameworks, including ICH E2B(R3), EMA EVMPD, FDA requirements, and GVP modules
  Collaborate with Quality Assurance to ensure systems are maintained in a validated state in accordance with GAMP 5, 21 CFR Part 11, and EU Annex 11
  Support and participate in internal and external audits and regulatory inspections related to PV systems
  Monitor the regulatory landscape and proactively identify impacts to systems from evolving guidance, communicating these to relevant stakeholders
  Ensure data integrity, traceability, and audit trail standards are upheld across all system interactions
• Operational Performance & Continuous Improvement
  Define, track, and report on system KPIs and performance metrics, driving continuous improvement initiatives based on operational data
  Identify and implement process optimizations at the intersection of business workflows and system capabilities
  Support business continuity planning related to system downtime, data recovery, and disaster recovery scenarios
  Contribute to strategic planning for the PV systems portfolio, including build/buy/partner evaluations and technology investment recommendations

Required Qualifications

• 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
• Demonstrated 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
• Key Skills and Competencies (Business and Stakeholder Skills)
• Business and Stakeholder Skills: Exceptional cross-functional communication — able to speak both "business" and "technology" fluently
• Strong project and program management skills; ability to manage multiple system workstreams simultaneously
• Proven ability to influence without authority across organizational levels and functions
• High-level analytical and critical thinking — able to assess complex problems and drive solutions
• Skilled in requirements gathering, business process mapping, and gap analysis
• Effective vendor management and negotiation capabilities
• Comfortable presenting to and engaging senior leadership
• Personal Competencies: Detail-oriented with a quality-first mindset
• Proactive, self-directed, and comfortable operating with ambiguity and autonomy
• Collaborative and empathetic — a natural team enabler and culture carrier
• Adaptable to a rapidly evolving technology and regulatory landscape
• Demonstrates integrity and accountability, especially in a patient safety context

Technical Knowledge Requirements

• PV Safety Databases & Case Management
  Hands-on familiarity (business user level) with leading safety databases. Understanding of E2B(R3) case data structure, ICSR processing workflows, MedDRA coding, and regulatory submission timelines (e.g., 7/15-day reporting)
• Reporting & Analytics Tools
  Experience with PV reporting platforms and dashboards, Power BI or equivalent BI tools for operational metrics
  CIOMS and PSUR/PBRER report generation workflows
  Ability to define and validate KPI reporting requirements in collaboration with data teams
• Signal Detection & Management Tools
  Familiarity with signal management platforms. Understanding of disproportionality analysis (PRR, ROR, EBGM) and signal workflow from detection through evaluation and escalation
  Knowledge of EudraVigilance and FDA FAERS database structures and access
• Literature Monitoring & Search Tools
  Experience with or oversight of systematic literature search tools. Understanding of ICSR extraction from literature, deduplication, and integration with safety databases. Awareness of AI-powered literature monitoring solutions and automation capabilities in this space
• Artificial Intelligence and Emerging Technologies
  Awareness of AI/ML applications in pharmacovigilance, including: AI-assisted case narrative generation and MedDRA auto-coding NLP for literature monitoring and social media surveillance
  Predictive analytics for signal detection and risk assessment
  Large Language Models (LLMs) and their responsible use in PV workflows
  Ability to critically evaluate AI vendor claims and assess technology fit for regulated PV environments
  Understanding of AI governance requirements in GxP contexts (data lineage, explainability, auditability)
• Data and Integration Knowledge
  Understanding of PV data flows and system integrations (e.g., CRO feeds, affiliate submissions, E2B gateway connections)
  Familiarity with HL7, FHIR, E2B XML data standards
  Comfort with data mapping, data quality principles, and working alongside data architects and engineers
  Basic understanding of API-based integrations and middleware concepts (not hands-on, but enough to direct and review)

Regulatory & Quality Frameworks

• Solid knowledge of GVP Modules (especially I, V, VI, VIII, IX, XVI)
• Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and CSV/CSA (Computer Software Assurance) principles
• Familiarity with ICH E2A, E2B, E2C, E2D, E2E guidelines
• Understanding of audit trail requirements, data integrity standards (ALCOA+), and inspection readiness
• Bachelor's degree in life sciences, pharmacy, medicine, nursing, public health, epidemiology, regulatory affairs, or a related field, or equivalent experience required.
• 4+ years of experience in pharmacovigilance, drug safety, epidemiology, risk management, scientific consulting, regulatory affairs, or a related field required.
• Certification in pharmacovigilance, drug safety preferred.
• Certification in regulatory affairs, clinical safety preferred.
• Certification in quality management, auditing preferred.

What Cencora offers

• Benefit offerings outside the US may vary by country and will be aligned to local market practice.
• The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Full time

Affiliated Companies: PharmaLex India Private Limited

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [e-mail]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned.

Cencora is a leading global pharmaceutical solutions company that is committed to improving the lives of people and animals everywhere. We connect manufacturers, providers, and patients to ensure that anyone can get the therapies they need, where and when they need them. We’re a purpose-driven organization, where all of our team members around the world are united in our responsibility to create healthier futures. We work together every day to help our partners bring their innovations to patients worldwide, creating unparalleled access and impact at the center of health.