EXPERIENCE : 6-8 years PRIMARY FOCUS : Project delivery & governance PMP preferred Work Mode : Hybrid We are a technology-led healthcare solutions provider, driven by our purpose to enable healthcare organizations to be future-ready.

We offer accelerated global growth opportunities for talent that is bold, industrious, and nimble. At Indegene, you gain a differentiated career experience at the convergence of healthcare and technology, guided by entrepreneurship, passion, innovation, collaboration, and empathy. We are looking for a PM Lead to drive successful, on-time, on-budget, and quality-compliant delivery of projects within the Global Safety and Pharmacovigilance Business Unit.

The role will partner with global and regional stakeholders, safety operations teams, medical and regulatory functions, technology teams, and external partners to define project scope, establish plans, manage dependencies, monitor progress, and measure outcomes. The PM Lead will retain end-to-end project management accountability while applying relevant pharmacovigilance considerations, including regulatory timelines, patient safety priorities, quality controls, inspection readiness, data privacy, and controlled change management. Collect, clarify, and document project requirements; Define project scope, goals, deliverables, timelines, milestones, resource needs, and success measures.

Build and maintain integrated project plans using appropriate project management tools. Manage project dependencies, critical paths, risks, assumptions, issues, decisions, and change requests. Liaise with project stakeholders on an ongoing basis and facilitate clear, timely decision-making.

Determine the frequency and content of project reporting; Capture stakeholder feedback on performance and delivery, translating insights into continuous improvement actions. Facilitate knowledge sharing, lessons learned, and adoption of project management best practices across the business unit. Apply project governance appropriate to pharmacovigilance and safety initiatives, with focus on patient safety, compliance, quality, and traceability.





Coordinate projects that may involve safety case operations, safety systems, aggregate reporting, signal management, risk management, literature activities, partner/vendor oversight, or regulatory safety submissions. Plan delivery around applicable reporting commitments, regulatory due dates, client service-level expectations, and internal quality checkpoints. Partner with Safety, Medical, Regulatory, Quality, Technology, Data Privacy, and Business Operations stakeholders to manage cross-functional dependencies.

Support controlled implementation of process, technology, migration, automation, and operating-model changes through impact assessment, readiness tracking, validation coordination, training, and stabilization planning. Maintain inspection- and audit-ready project documentation, including approvals, decisions, risks, actions, change history, and evidence of completion. Monitor quality and compliance indicators relevant to the project and ensure deviations, risks, and corrective actions are escalated through the appropriate governance forums.

Coordinate global, regional, and local requirements without losing alignment to the agreed project scope and delivery model. Handle safety-related information with appropriate confidentiality, access control, and data integrity awareness.

Project

Governance and Delivery # Understand and communicate project scope, goals, deliverables, acceptance criteria, and stakeholder expectations. # Support leadership reviews with concise reporting on schedule, budget, scope, quality, compliance, resource capacity, risks, and dependencies. # Identify and resolve issues and conflicts within the project team; escalate material risks early with clear impact and mitigation options.



# Define project success criteria and ensure they are understood by all involved parties throughout the project lifecycle. # Drive project closure, benefits review, documentation handover, lessons learned, and transition to business-as-usual operations. 6-8 years of experience in a project management capacity within life sciences, healthcare, pharmaceutical services, consulting, or a related regulated environment. ~ Hands-on experience managing cross-functional projects across scope, schedule, cost, quality, risk, resource, communication, and stakeholder dimensions. ~ Working understanding of pharmacovigilance or drug safety processes and the importance of regulatory timelines, quality controls, and patient safety. ~ Strong written, oral, facilitation, presentation, and stakeholder-management skills. ~ Experience with project management tools and proficiency in Microsoft Office applications. MBA, M.Pharm, Pharm.D, MSc in Life Sciences, or another relevant postgraduate qualification. Prior experience in pharmacovigilance, drug safety, pharmaceutical consulting, safety operations, or healthcare agency environments.

Exposure to one or more areas such as individual case safety reports, safety databases, aggregate safety reports, signal management, risk management, literature surveillance, regulatory submissions, or safety agreements.

Experience supporting technology implementation, data migration, process transition, automation, validation, or change management in a regulated environment.

Experience collaborating with global teams, clients, vendors, and matrixed stakeholders across time zones. Ability to conduct research into project-related issues, understand recent concepts quickly, and translate them into practical delivery actions. Interest in emerging technologies and their responsible application to project delivery and pharmacovigilance operations. PMP, PRINCE2, Agile/Scrum, or comparable project management certification is an added advantage.

Risk Management Quality Focus

Indegene is proud to be an Equal Employment Opportunity employer and is committed to a culture of inclusion and diversity.

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