What You’ll Do:

Reporting to the Senior Director, Patient Safety and Pharmacovigilance (PSPV) Operations, the Senior Manager, Patient Safety and Pharmacovigilance Quality is responsible for maintaining and improving the pharmacovigilance (PV) quality system. They will ensure that day-to-day activities are in compliance with regulatory requirements, lead continuous improvement initiatives, and actively support PSPV audits and inspections.

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

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

Required Qualifications:

• 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

Preferred Qualifications:

• Prior PV quality and compliance and vendor management experience preferred

 

Education:

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