Job Description

Location:

USA/Europe

~85% Virtual, ~15% In-person

Job Type: Contractor role (~2 days per week).

About Us:

The Pistoia Alliance is a member-driven, 501(c)(6) non-profit life sciences industry group dedicated to advancing innovation in research and development through pre-competitive collaboration. Our diverse membership includes pharmaceutical companies, industry vendors, publishers, consulting practices, academic institutions, and government organizations. The Pistoia Alliance fulfils its mission primarily through member-driven projects and by hosting conferences, webinars, and networking events. 

Role Overview:  

We are seeking an experienced, domain-aware, and energetic project manager / business analyst to manage a multi-company, pre-competitive collaboration project in pharmacovigilance. 

This role offers a unique opportunity to engage with leading pharmaceutical companies, facilitating collaboration across organizations with differing priorities and ensuring the success of this industry-wide initiative. 

The ideal candidate will excel in balancing project management and business analysis tasks, driving the definition of common, cross-company business, functional, and operational requirements, and elucidating and documenting the alignment of data architectures and APIs to support pharmacovigilance workflows. 

Well-developed leadership, communication, and organizational skills are essential to navigate the complexities of pre-competitive collaborative projects in the pharmaceutical industry. 

The Pistoia Alliance Pharmacovigilance Project  

Pharmacovigilance is a regulatory requirement for any company involved in the development and/or marketing of therapeutics for human use. 

There is a limited number of companies providing technology, support and services for pharmacovigilance. 

Given its critical and regulated nature, pharmacovigilance presents an ideal opportunity to establish a multi-company community to identify and document common, cross-industry business, functional, and operational requirements, data architectures, and APIs. To provide the supply-side companies clear guidance on the types and functionality of their products and services. 

This project will start its work by focusing on “Case Intake”—a key component of pharmacovigilance workflows. 

Key Responsibilities:  

Project Management   

• Oversee the planning, execution, and completion of a multi-company pharmacovigilance project, ensuring alignment with all stakeholders. 
• Maintain project timelines, budgets, and deliverables while navigating the complexities of a pre-competitive collaboration environment. 

Business Analysis & Requirements Gathering  

• Identify and document common, cross-company business, functional, and operational requirements, ensuring alignment across pharmaceutical companies, technology providers, and regulators. 
• Define and document data architectures and APIs to enhance interoperability and compliance in pharmacovigilance case intake workflows. 
• Analyse existing pharmacovigilance business processes, identifying gaps and opportunities for improvement through standardisation, technology and automation. 
• Work closely with stakeholders to translate business needs into actionable project deliverables. 

Stakeholder Engagement & Facilitation  

• Foster strong relationships with existing and new contributors, ensuring their input is effectively integrated into the project. 
• Facilitate virtual and in-person meetings, workshops, and discussions, ensuring active participation and alignment on project objectives. 
• Manage conflicting priorities and perspectives, facilitating consensus and maintaining project momentum. 

Tracking & Reporting  

• Use Pistoia Alliance project tracking systems to monitor milestones, deliverables, timelines and costs, providing regular updates to stakeholders. 
• Ensure project progress is communicated effectively to sponsors, working groups, and the Pistoia Alliance leadership team. 

Qualifications/Experience:  

• Educational Background: Bachelor’s or advanced degree in life sciences, pharmacy, biomedical informatics, regulatory science, or a related field. 
• Experience: Minimum of 5 years in pharmacovigilance, with at least 2 years in project management and/or business analysis roles. 
• Business Analysis Skills: Experience in gathering business, functional, and operational requirements, defining specifications, and analysing workflows in a pharmacovigilance or regulatory setting. 
• Project Management Skills: Ability to manage complex, multi-company projects, demonstrating strong organizational and leadership capabilities. 
• Communication Skills: Excellent verbal and written communication skills, with the ability to facilitate discussions and effectively translate technical and business needs. 
• Interpersonal Skills: Strong ability to build relationships, manage conflicts, and work collaboratively with diverse teams. 

Preferred Qualifications/Experience:  

• Experience managing pre-competitive collaboration multi-company projects in the pharmaceutical industry. 
• Project Management Professional (PMP), PRINCE2, or Business Analysis certification (e.g., CBAP, CCBA). 
• Knowledge of pharmacovigilance regulations (e.g., ICH E2E, GVP, FDA, EMA, MHRA requirements). 
• Knowledge of Agile development methodologies.

What We Offer:  

• Industry Engagement: Unique opportunity to collaborate with leading pharmaceutical companies, expanding your professional network. 
• Professional Growth: Experience managing high-impact, high-visibility, pre-competitive projects, enhancing your leadership, project management, and business analysis skills. 
• Innovative Environment: Work in a dynamic and collaborative team dedicated to advancing pharmacovigilance practices through shared expertise and resources. 

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