Project Manager, Pharmacovigilance

About Inizio

Inizio is a global partner with over 10,500 experts operating in more than 50 countries. We support health and life science companies by turning science into strategy and executing across the product and patient journey.

About Advisory

Inizio Advisory is a trusted advisor for health and life science companies that turns science into strategy, supporting execution at every stage of the product and patient journey from early commercialization to launch and beyond.

Role Overview

Inizio Advisory is seeking a talented and detail-oriented individual to support the execution and management of pharmacovigilance (PV) compliance and reporting processes for their Putnam Associates business.

The Quality, Risk and Compliance Project Manager will provide direct support to case teams and will focus on improving Putnam's pharmacovigilance and compliance processes as a firm. The role requires a team-player who thrives in a fast-paced environment and takes a proactive approach to problem solving.  This role is critical to support the execution and management of Quality, Risk and Compliance, with a focus on pharmacovigilance (PV) compliance and reporting processes.

This role will operate within Advisory's Operational Efficiency and Effectiveness organization, which is tasked with providing best-in-class support to Putnam's consulting team with regards to PV compliance.

Here's what you'll be doing

• Provide support to the Quality, Risk, and Compliance Lead on case management activities to ensure AE information is processed according to documented timelines and quality standards.
• Support the Quality, Risk, and Compliance Lead with pre-audit preparations, audit co-conduction, and post audit CAPA management.
• Lead internal audits for client audit preparedness.
• Monitor the implementation of processes outlined in client PV agreements and safety management plans.
• Manage internal CAPA tracker and oversee completion and CAPA close-outs.
• Train consulting staff and new hires, and track training completion for new and updated client PV processes.
• Provide guidance and support in the review and submission of Adverse Events (AE)/SAE reconciliations, Internal project close-out activities, and other quality requirements.
• Maintain internal PMR and project milestone repository.
• Manage, track, and coordinate compliance training for consulting team members across various clients.
• Provide content guidance, as needed, for all safety documentation.
• Train third-party vendors on clients' PV compliance standards.
• Assist consultants in addressing technical issues with PV client platforms.
• Field various client and internal QC questions.
• Aid and expedite market research fielding approvals, ensure documentation is maintained according to regulatory requirements in project folders.
• Assist with creation and revision of appropriate quality and compliance policies, SOPs, processes, and best practices as to adhere to client PVAs.
• Partner with various stakeholders to proactively identify and mitigate compliance risks, and escalate critical compliance risks to the Quality, Risk, and Compliance Lead.

Here's what you'll need:

• Demonstrated experience in PV case management or related compliance work.
• Familiarity with pharmacovigilance regulations (GVP, FDA, EMA).
• Experience collaborating across consulting or client-facing environments.
• Strong documentation and process improvement mindset.
• Bachelor's degree in Life Sciences or Business preferred.
• Experience working with Excel, PowerPoint, and MS Word.
• Smartsheet familiarity preferred.
• Outstanding attention to detail and organizational skills.
• Excellent project management skills.
• Strong analytical skills and ability to use data to develop business insights.
• Ability to succeed in a fast-paced, growth-oriented environmen

Our Pledge

At Inizio, we value inclusivity, recognize the power of diversity, and inspire the next generation of change-makers. We are an equal opportunities employer and are committed to creating a dynamic work environment that values diversity, equity, and inclusion.

Don't meet every job requirement? That's okay Our company is dedicated to building a diverse, inclusive, and authentic workplace. If you're excited about this role, but your experience doesn't perfectly fit every qualification, we encourage you to apply anyway. You may be just the right person for this role or others.