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Kailera Therapeutics · 2 days ago

Senior Manager, Patient Safety and Pharmacovigilance Quality

Waltham, Massachusetts

Full-time

Hybrid

Senior Level, Lead/Staff

$136K/yr - $170K/yr

8+ years exp

Kailera is committed to developing therapies that transform lives and improve health. The Senior Manager, Patient Safety and Pharmacovigilance Quality will maintain and enhance the pharmacovigilance quality system, ensuring compliance with regulatory requirements and leading continuous improvement initiatives.

BiotechnologyPharmaceuticalTherapeutics

Responsibilities

Monitor global regulatory requirements, procedures, and guidance (e.g., ICH, FDA, EMA, MHRA, TGA, and ICH-GCP/ICH-E2E guidelines, etc.) and assess impact on existing procedures and recommending updates

Working knowledge of global PV regulations, including FDA and ICH guidelines

Develop and maintain quality metrics for PSPV operations (e.g., SAE case reconciliation, inline and retrospective ICSR review, etc.)

Identify process gaps and develop stage-appropriate solutions within PSPV and the safety vendor

Support the development and maintenance of PSPV departmental Key Performance Indicators (KPI), Key Quality Indicators (KQIs), and monthly compliance metrics

Develop and implement processes for the management of all PSPV procedures and controlled documents (e.g., Policies, SOPs, WIs)

Track PV deviations, compliance issues, or other quality events

Contribute to CAPA development, review, monitor, and trend root cause analyses and propose preventive actions

Partner with Quality Assurance and other key stakeholders and provide PSPV input into organizational initiatives (e.g. quality monitoring, system implementations/improvements, process changes, inspection readiness)

Contribute to the maintenance of PSPV Pharmacovigilance Agreements

Support PSPV document review activities (e.g., signal detection, DSUR, risk management plans, literature review, etc.)

Maintain inspection readiness for PSPV activities, including support for audits and health authority inspections

Support TMF filing activities

Track PSPV commitments from internal audits, regulatory inspection findings, safety vendor non-compliance, and CAPAs

Provide PSPV compliance training to internal and external teams

Promote a culture of compliance, operational excellence, and continuous improvement within the PSPV team and cross-functionally

Drive and/or support initiatives to standardize procedures, improve efficiency, and manage change within PSPV operations

Participate in PSPV and cross-functional team meetings and in vendor governance activities (e.g., KPI review, quality metrics, deviation tracking, etc.)

Other activities/responsibilities as required

Qualification

Drug Safety/PharmacovigilanceGlobal PV regulationsAudits/InspectionsCAPA managementQuality investigationsProject managementMicrosoft WordMicrosoft ExcelCommunication skillsOrganizational skillsInterpersonal skills

Required

Minimum of 8+ years of experience in Drug Safety/Pharmacovigilance (specifically, PV quality and compliance, and/or operations) within the pharmaceutical or biotechnology industry

Knowledge of global safety and PV regulations, guidelines, and industry standards (FDA, EMA, ICH, GVP, GxP)

Demonstrated experience in audits/inspections, quality investigations, or CAPA management

Proven ability to identify issues, analyze root causes, propose, and implement effective solutions

Strong organizational, time management, and project prioritization skills, including excellent verbal and written communication and interpersonal skills, and proficient computer skills, including Microsoft Word and Excel

Demonstrated ability to work collaboratively in a fast-paced, cross-functional, and matrixed environment, and adaptable to changing priorities

Must be able and willing to travel on occasion

Bachelor's degree in Life Sciences (or equivalent experience) or a related field required. (BS, RN, preferred)