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Kailera Therapeutics · 17 hours ago

Associate Director, Pharmacovigilance Project Management (Planning and Innovations)

Waltham, Massachusetts

Full-time

Hybrid

Lead/Staff, Director/Executive

$160K/yr - $200K/yr

10+ years exp

Kailera is committed to developing therapies that empower individuals to transform their lives and improve their health. The Associate Director of Pharmacovigilance Project Management will oversee the operational effectiveness and project planning of global patient safety and pharmacovigilance activities, integrating innovative technologies and driving process optimization.

BiotechnologyPharmaceuticalTherapeutics

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

Qualification

PharmacovigilanceStakeholder EngagementRegulatory KnowledgeProject ManagementProcess ImprovementAnalytical SkillsStrategic PlanningComputer SkillsCommunication SkillsInterpersonal SkillsOrganizational SkillsAdaptability

Required

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)