Senior Manager, Patient Safety and Pharmacovigilance Quality - Boston
2 days ago
Job description
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health.
Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera's mission to advance novel therapies for obesity and related conditions.
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence.As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
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)
Salary Range
$143,000—$175,000 USD
For Full Time Roles:
This range represents the company's good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown.
Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.
Equal Employment Opportunity InformationKailera Therapeutics, Inc.
is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
E-VerifyKailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
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