Project Manager – Pharmacovigilance (Quality, Risk & Compliance)
Location: Gurugram, India
Employment Type: Full-Time
Work Model: Onsite / Hybrid (as per business requirement)
Job Function: Pharmacovigilance | Quality & Compliance | Project Management
Industry: Life Sciences / Pharmaceuticals / Consulting
About Inizio
Inizio is a global commercialization partner for health and life sciences companies, with 10,500+ experts across 50+ countries. Inizio supports organizations across the entire product and patient journey—turning science into strategy and executing with precision to deliver meaningful outcomes for patients worldwide.
About Inizio Ignite
Inizio Ignite is the global advisory arm of Inizio, combining expertise from Putnam, Vynamic, STEM, and Research Partnership. The organization partners with leading pharmaceutical and life sciences companies to drive transformation across R&D, Medical Affairs, access & pricing, and commercialization using strategy, insights, and innovation.
Role Overview
Inizio Ignite is seeking a Project Manager – Pharmacovigilance (Quality, Risk & Compliance) to support and strengthen pharmacovigilance compliance and reporting processes for its Putnam Associates consulting business.
This role plays a critical function in managing PV compliance, audit readiness, and quality processes, supporting consulting case teams and ensuring adherence to global pharmacovigilance regulations, client PV agreements, and internal SOPs.
The position sits within Ignite’s Operational Efficiency & Effectiveness organization, which delivers best-in-class compliance and operational support to consulting teams.
Key Responsibilities
Support the Quality, Risk & Compliance Lead in managing pharmacovigilance case activities and ensuring timely and high-quality processing of adverse event (AE) information
Support pre-audit preparation, audit participation, and post-audit CAPA management
Lead internal audits to ensure client audit readiness
Monitor and ensure compliance with client Pharmacovigilance Agreements (PVAs) and Safety Management Plans
Maintain and manage CAPA trackers, ensuring timely completion and close-out
Train consulting staff and new hires on client-specific PV processes, and track training compliance
Provide guidance on AE/SAE reconciliations, project close-out activities, and safety documentation
Maintain internal Project Milestone Repository (PMR) and compliance tracking tools
Manage and coordinate PV compliance training across multiple client projects
Provide content and technical guidance for safety and compliance documentation
Train third-party vendors on client PV requirements and compliance standards
Support consultants with PV platform-related technical issues
Respond to internal and client quality and compliance queries
Support market research fielding approvals and ensure documentation is maintained per regulatory standards
Assist in the development, review, and revision of PV policies, SOPs, and best practices
Proactively identify compliance risks, support mitigation strategies, and escalate critical risks appropriately
Required Qualifications & Skills
Demonstrated experience in pharmacovigilance case management, quality, or compliance
Strong knowledge of global PV regulations including GVP, FDA, and EMA requirements
Experience working in consulting or client-facing environments
Strong documentation, audit, and process improvement mindset
Bachelor’s degree in Life Sciences or Business (preferred)
Proficiency in Microsoft Excel, PowerPoint, and Word
Familiarity with Smartsheet is an advantage
Excellent project management, organizational, and analytical skills
High attention to detail and ability to manage multiple priorities
Ability to work effectively in a fast-paced, growth-oriented environment
Why Join Inizio Ignite?
Work at the intersection of pharmacovigilance, consulting, and compliance
Exposure to global clients and complex PV frameworks
Strong emphasis on career development, learning, and inclusion
Be part of a mission-driven organization shaping the future of healthcare
Equal Opportunity Statement
Inizio is an equal opportunity employer committed to diversity, equity, and inclusion. We encourage applications from all qualified individuals and value diverse perspectives that strengthen our teams and outcomes.
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