Apply on Employer Site

Kailera Therapeutics · 5 days ago

Manager, Patient Safety and Pharmacovigilance Operations

Waltham, Massachusetts

Full-time

Hybrid

Mid, Senior Level

$110K/yr - $140K/yr

6+ years exp

Kailera is committed to developing therapies that transform lives and enhance health. The Manager of Patient Safety and Pharmacovigilance Operations will oversee safety vendor activities, ensuring compliance with regulations and quality standards while promoting operational excellence within the team.

BiotechnologyPharmaceuticalTherapeutics

Responsibilities

Act as a subject matter expert on emerging global guidelines and regulations, assessing impact on existing procedures, and recommending updates

Support PSPV Operations in the development and maintenance of safety vendor documentation (e.g., SMP, SAE/AESI, Pregnancy Reporting forms, etc.)

Responsible for the oversight of the safety vendor ICSR case processing and reporting activities (e.g., ensuring high quality and compliant case processing and submission activities including narrative writing, coding (MedDRA), query resolution, reports generation, study closure, etc.), SAE Reconciliation support, and safety vendor metrics (e.g., KPIs and KQIs, etc.) as defined in the SMP

Act as primary day-to-day liaison with the safety vendor project manager and team leads to ensure efficient case workflow to meet PSPV and alliance partner obligations

Support in-line and/or retrospective case quality review (e.g., to assess coding accuracy, narrative completeness, data integrity, regulatory compliance, etc.)

Develop and maintain a robust and easily navigable PSPV SharePoint repository

Document, track, and escalate issues or quality trends as per process and the PV Quality Agreement. Identify process or quality gaps and contribute to effective, stage appropriate, and compliant solutions

Collaborate with the safety vendor to provide timely delivery of internal and external safety database data extract requests and support safety database activities (e.g., database updates, processes, new study configurations, access issue escalations, case processing conventions, system implementation/transitions, etc.)

Contribute to controlled document development and maintenance (e.g., SOPs, WIs, SAE/pregnancy forms, SMPs, etc.) and support inspection readiness activities

Support PSPV Aggregate reporting activities (e.g., signal detection, DSUR, risk management, literature review, etc.), as required

Promote a culture of compliance, operational excellence, and continuous improvement within the PSPV team and ensure effective communication with internal and external shareholders

Empowered to drive and/or support initiatives to standardize procedures, improve efficiency, and manage change within operations and PSPV as a whole

Support TMF filing activities

Participate in internal and external team meetings (e.g., clinical study team meetings, safety vendor governance activities, alliance meetings, etc.)

Qualification

Drug Safety OperationsPharmacovigilance RegulationsSafety Database ManagementVendor ManagementProject ManagementMicrosoft WordMicrosoft ExcelCommunication SkillsOrganizational SkillsAdaptability

Required

Minimum of 6+ years of experience in Drug Safety/Pharmacovigilance Operations within the pharmaceutical or biotechnology industry

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

Demonstrated working knowledge of safety databases (e.g., Argus), especially reports generation, PV dashboard, etc

Demonstrated ability to work collaboratively in a fast-paced, cross-functional, and matrixed environment with strong organizational, time management, and project prioritization skills

Excellent verbal and written communication and interpersonal skills

Prior PV Operations and safety vendor management experience required

Adaptable to changing priorities

Proficient computer skills, including Microsoft Word and Excel

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)