Project Manager - Pharmacovigilance

Why This Role Matters

The Project Manager – Pharmacovigilance plays a mission-critical role in ensuring the highest standards of quality, compliance, and patient safety within Inizio Ignite’s advisory and consulting operations. In the evolving life sciences landscape, pharmacovigilance compliance is not just a regulatory requirement but a strategic enabler of trust, scientific integrity, and patient impact. This role supports Putnam Associates and broader advisory teams by strengthening adverse event reporting, audit readiness, and compliance governance frameworks. By ensuring adherence to global pharmacovigilance standards such as GVP, FDA, and EMA guidelines, the role directly contributes to safeguarding patients, protecting client reputation, and maintaining regulatory excellence. In a fast-paced consulting environment, this position ensures that operational efficiency and regulatory precision coexist seamlessly, transforming compliance from a reactive function into a proactive strategic advantage.

Job Description

The Project Manager – Pharmacovigilance (Quality, Risk & Compliance) will oversee and support the execution of pharmacovigilance compliance and reporting processes within Inizio Ignite’s Operational Efficiency and Effectiveness function. The role involves collaboration with consulting teams, clients, and cross-functional stakeholders to ensure adverse event processing, audit management, training compliance, and documentation standards meet global regulatory expectations. The individual will act as a compliance partner to consulting case teams, ensuring pharmacovigilance agreements, safety management plans, and quality processes are executed accurately and efficiently. The role demands strong project management capabilities, regulatory understanding, and a proactive mindset to identify, mitigate, and escalate compliance risks.

Key Features of the Role:

• Hybrid working model based in Gurugram
• Strategic exposure to global life sciences clients
• Direct involvement in pharmacovigilance compliance governance
• Cross-functional collaboration with consulting, risk, and regulatory teams
• Audit readiness and CAPA leadership responsibilities
• Opportunity to drive process improvement and operational excellence

Responsibilities

• Support case management activities to ensure timely and accurate AE processing
• Assist in pre-audit preparation, audit coordination, and post-audit CAPA management
• Lead internal audit preparedness initiatives for client engagements
• Monitor implementation of pharmacovigilance agreements and safety management plans
• Maintain and manage CAPA trackers, ensuring timely closure of corrective actions
• Conduct compliance training for consulting teams and track completion status
• Review and support submission of AE/SAE reconciliations and project close-out documentation
• Maintain project milestone repositories and compliance documentation archives
• Coordinate compliance requirements across multiple client engagements
• Provide content guidance for safety documentation and regulatory reporting
• Support vendor training on client PV compliance standards
• Address technical and operational issues related to PV client platforms
• Assist in development and revision of SOPs, compliance policies, and best practices
• Identify compliance risks proactively and escalate critical concerns appropriately

Required Qualifications

• Demonstrated experience in pharmacovigilance case management or compliance
• Familiarity with global PV regulations including GVP, FDA, and EMA requirements
• Strong understanding of audit management and CAPA processes
• Experience working in consulting or client-facing environments preferred
• Proficiency in Microsoft Office tools including Excel, PowerPoint, and Word
• Smartsheet familiarity preferred

Educational Requirements:

• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or Business
• Advanced degree preferred but not mandatory

Experience and Skills:

• Minimum 2 years of relevant experience in pharmacovigilance or regulatory compliance
• Strong documentation and process improvement orientation
• Excellent project management and organizational skills
• High attention to detail and analytical thinking ability
• Ability to interpret regulatory guidelines and implement compliance processes
• Strong communication and stakeholder engagement skills
• Ability to work independently in a fast-paced, growth-oriented environment
• Agile mindset with strong business acumen

Age Eligibility:

No specific age criteria are mentioned. Candidates must meet educational and professional qualification requirements.

Salary Insights

Compensation is competitive and aligned with industry standards for pharmacovigilance project management roles in India. Salary may vary based on experience, expertise in regulatory compliance, and consulting exposure. Additional benefits may include performance incentives, hybrid work flexibility, and professional development opportunities.

Company Overview

Inizio Ignite is part of the global Inizio group, a leading partner to health and life sciences organizations. With over 10,500 experts across more than 50 countries, Inizio supports companies across the product lifecycle from early development to commercialization and beyond. Inizio Ignite combines strategy, innovation, research partnership, and consulting expertise to drive transformation in healthcare. Through its Putnam strategy consulting arm, the organization bridges science and strategy, enabling confident decision-making for pharmaceutical, biotech, and medical device clients. Guided by purpose, precision, and passion, Inizio Ignite is committed to delivering measurable impact while fostering diversity, inclusion, and innovation within its global workforce.

FAQ

1. Is this role client-facing?
   Yes, the role involves collaboration with client teams and consulting case teams to ensure PV compliance alignment.

2. Is prior pharmacovigilance experience mandatory?
   Yes, demonstrated experience in PV case management or compliance is required.

3. Does the role require travel?
   Travel requirements may vary depending on audit and client engagement needs.

4. Is this a leadership role?
   This role provides leadership in audit preparedness, CAPA management, and compliance governance within consulting engagements.

5. Is remote work allowed?
   The position follows a hybrid work model in Gurugram

Application Tips

• Highlight pharmacovigilance case management and compliance experience clearly in your CV
• Demonstrate familiarity with GVP, FDA, and EMA regulatory frameworks
• Showcase audit experience, CAPA management, and SOP development exposure
• Emphasize cross-functional collaboration and consulting exposure
• Quantify achievements such as audit readiness improvements or compliance efficiency gains
• Tailor your resume to highlight regulatory precision, project management capabilities, and analytical strengths