Project Lead

Indegene; Bengaluru; Hybrid; INR 2,500,000 - 4,500,000; Full time

Job summary

Indegene is seeking a PM Lead to drive on-time, on-budget delivery for Global Safety and Pharmacovigilance projects. You will partner with global stakeholders, safety operations, medical, regulatory, and technology teams to define scope and plan delivery.

You will apply pharmacovigilance considerations including regulatory timelines, patient safety priorities, data privacy, and quality controls while maintaining inspection readiness and controlled change management.

Qualifications

• 6-8 years of project management experience in life sciences, healthcare, or regulated environments.
• Hands-on cross-functional project leadership across scope, schedule, cost, quality, and risks.
• Understanding of pharmacovigilance processes and regulatory timelines.
• Ability to operate in fast-paced global environments and keep delivery discipline.
• Strong written, oral, facilitation, and stakeholder-management skills.
• PMP, PRINCE2, Agile/Scrum certification is an added advantage.

Responsibilities

• Collect, clarify, and document project requirements and coordinate best-fit solutions.
• Define scope, goals, deliverables, timelines, milestones, resources, and success metrics.
• Develop and maintain integrated project plans with PM tools.
• Manage dependencies, risks, issues, and change requests.
• Coordinate cross-functional teams and external partners for timely delivery.
• Produce status reports, governance updates, and requirements docs.
• Ensure compliance with pharmacovigilance standards and regulatory timelines.
• Maintain audit-ready project documentation and evidence of completion.

Skills

Project management

Pharmacovigilance knowledge

Cross-functional collaboration

Stakeholder management

Communication

Education

MBA, M.Pharm, Pharm.D, MSc in Life Sciences

Tools

Microsoft Office

Job description

WORK MODEL:

Global stakeholder collaboration

CERTIFICATION:

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 purpose-driven, customer-obsessed, bold in our actions, nimble in our decision-making, and industrious in the way we work. Explore opportunities at www.careers.indegene.com

Job Summary

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.

Core Responsibilities

• Collect, clarify, and document project requirements; assess options and coordinate best-fit solutions.


• 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.


• Coordinate cross-functional teams and external partners to ensure timely handoffs and delivery accountability.


• Liaise with project stakeholders on an ongoing basis and facilitate clear, timely decision-making.


• Develop and deliver status reports, governance updates, proposals, requirements documentation, and presentations.


• Determine the frequency and content of project reporting; analyse results and troubleshoot problem areas.


• 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.

Global Safety and Pharmacovigilance Nuances

• 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.


• Create governance cadence, meeting structure, decision forums, status reporting, and escalation pathways.


• 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; elevate 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.

Must Have

• 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.


• Ability to operate effectively in a fast‑paced and sometimes ambiguous global environment.


• Strong sense of urgency, ownership, accountability, and attention to detail.


• Ability to adapt quickly to changing work demands and priorities while maintaining delivery discipline.


• Strong written, oral, facilitation, presentation, and stakeholder‑management skills.


• Experience with project management tools and proficiency in Microsoft Office applications.

Desired Profile

• 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 new 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.

Delivery Leadership

Plans rigorously and drives outcomes.

Safety Mindset

Keeps patient safety and compliance visible.

Stakeholder Alignment

Builds clarity across global teams.

Anticipates, mitigates, and escalates early.

Quality Focus

Responds effectively to changing priorities.

Communication

Conveys complex information concisely.

Uses insights to strengthen delivery.

Indegene is proud to be an Equal Employment Opportunity employer and is committed to a culture of inclusion and diversity. Employment decisions are based on business requirements, candidate merit, and qualifications. All qualified applicants will receive consideration for employment without regard to characteristics protected by applicable law.