Senior Specialist, Pharmacovigilance System

MWI Animal Health; India; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

MWI Animal Health is seeking a Senior Specialist, Pharmacovigilance System to serve as the system champion for PV platforms, ensuring regulatory and operational excellence across the lifecycle. You will bridge PV operations with IT, define requirements, and lead governance, documentation, and validation activities.

The role demands PV domain expertise, stakeholder management, and a forward-looking view on AI-enabled PV solutions, with strong collaboration across Quality, Regulatory, and IT teams.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, nursing, health informatics, or related field.
• 4+ years of experience in pharmacovigilance, drug safety, or related discipline.
• Experience owning or managing PV systems or technology platforms in a business capacity.

Responsibilities

• Own and govern PV platforms and systems across lifecycle from requirements to retirement.
• Translate business/regulatory needs into clear technical requirements for IT.
• Lead change management, training, and stakeholder engagement for system rollouts.
• Ensure compliance with ICH E2B(R3), GxP, 21 CFR Part 11, and EU Annex 11.
• Monitor KPIs and drive continuous improvement in PV systems.

Skills

Cross-functional communication

Project management

Stakeholder management

PV systems ownership

Regulatory compliance

Data analytics

Vendor management

AI in PV governance

Education

Bachelor's degree in Life Sciences, Pharmacy, Nursing, Health Informatics or related

Tools

PV safety databases

Power BI

E2B(R3) data structures

Job description

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* 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.