What You Will Do:

Reporting to the Senior Vice President, Patient Safety and Pharmacovigilance, this individual will play a critical role in ensuring the operational effectiveness, project planning, and cross-functional alignment of global patient safety and pharmacovigilance activities. Lead and support the integration of innovative technologies, drive process optimization, and other cross-functional initiatives from concept to adoption. Combine knowledge of pharmacovigilance practices with strong project management, stakeholder leadership, and business acumen.

 

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Coordinate and lead departmental planning activities for the PSPV organization including, e.g., headcount modeling, organizational design, and pharmacovigilance projects
• Lead end-to-end project management for PV initiatives, including system implementations, process improvements, compliance programs, and organizational change efforts
• Develop and maintain project plans, metrics, and dashboards to support PSPV strategies
• Support resource forecasting, alliance management, and vendor oversight
• Facilitate cross functional meetings, track actions, and ensure on-time execution of project deliverables
• Communicate project updates to internal and external stakeholders through clear status reports, presentations, and dashboards
• Ensure project outcomes align with PV strategy and broader corporate objectives
• Build strong working relationships with cross functional leaders to support a proactive and collaborative safety culture
• Manage and coordinate cross functional alignment for operational effectiveness and PV system/process evolution
• Develop and maintain the pharmacovigilance innovation roadmap aligned with cross functional initiatives and compliance requirements
• Assist with the development and implementation of innovative technical or procedural solutions to improve PSPV operational capabilities
• Facilitate the maintenance of governance structures (e.g., Medical Safety Board)
• Support in GCP and GVP inspection readiness and support audits

Required Qualifications:

• 10+ years of experience in biotech, pharma or CRO with a demonstrated focus on pharmacovigilance, drug safety, or related field
• 3+ years of project or program management experience in a regulated environment
• Demonstrated project management skills with strong analytical and problem-solving capabilities
• Exceptional communication, stakeholder engagement, and change management skills
• Strong interpersonal, organizational, and strategic planning skills
• Experience working with outsourced vendors or Contract Research Organizations (CROs)
• Experience leading or supporting process improvement
• Adaptable to changing priorities and across multiple clinical trials and deliverables
• Adept at communicating departmental vision, effectively aligning activities and performance to achieve functional area goals in alignment with corporate objectives
• Proficient computer skills, including Word, PowerPoint, Excel, Visio, Power BI or similar.
• Proven experience working independently with minimal supervision
• Knowledge of global safety and PV regulations, guidelines, and industry standards (FDA, EMA, ICH, GVP)

Preferred Qualifications:

• Experience in other areas of drug development such as regulatory affairs, quality assurance or alliance management
• Hands-on experience with safety databases (e.g., Argus), PV quality systems, and regulatory inspections
• Familiarity with AI/ML and NLP in regulated settings

Education:

• Bachelor’s degree or equivalent in Life Sciences, Public Health, Business or other related fields is required. MBA, PhD, PharmD, RN or Master’s degree are preferred