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Kailera Therapeutics · 3 days ago

Associate Director, Integrated Pharmacovigilance Operations

Greater Boston

Contract

Onsite

Lead/Staff, Director/Executive

$160K/yr - $200K/yr

10+ years exp

Kailera Therapeutics is committed to developing therapies that empower individuals to transform their lives and enhance their health. The Associate Director, Integrated Pharmacovigilance Operations will oversee pharmacovigilance operational activities, ensuring compliance with global regulatory requirements and contributing to the development of pharmacovigilance strategies and efficiencies.

BiotechnologyPharmaceuticalTherapeutics

Responsibilities

Ensure compliance with global regulatory guidance and requirements (e.g., ICH, FDA, EMA, MHRA, TGA, etc.) and ICH-GCP/ICH-E2E guidelines to meet all applicable safety reporting requirements

Ensure that Individual Case Safety Reports (ICSR) and queries for assigned products are Reviewed for completeness and accuracy and submitted/distributed per global requirements and applicable SOP

Assist with data reconciliation and support safety signal management and aggregate data review activities

Contribute to the preparation and review of Safety Management Plans (SMP) for clinical trials

Support the continuous sponsor oversight of the global safety database and safety vendor activities with appropriate governance implementation

Assist with the development and implementation of innovative technical or procedural solutions to improve pharmacovigilance and safety operational capabilities

Assist in production and revision of pharmacovigilance and safety procedures, clinical trial documents and forms (e.g., IB, protocols, EDC CRF pages, etc.)

Contribute to regulatory filings and reviews (including BLAs/MAAs/INDs/CTAs), including responses to regulatory queries as needed

Represent pharmacovigilance and safety on project and study teams. Work closely with cross-functional team members to ensure accurate and efficient safety data collection

Work with quality assurance colleagues to address safety-related GCP/GVP compliance issues and support the implementation of corrective actions

Support the development and maintenance of inspection readiness activities, identify and participate in process improvement initiatives

Assist in GCP and GVP inspection readiness and support audits

Qualification

Pharmacovigilance operationsFDA regulationsICH guidelinesGCP complianceSafety databasesICSR processingData reconciliationCommunication skillsNegotiation skillsTeam collaboration

Required

A minimum of 10 years of pharmaceutical experience with a demonstrated focus in PV operations and compliance

Thorough knowledge of relevant FDA and International Conference on Harmonisation (ICH) guidelines, including Good Clinical Practices (GCP) guidelines

Strong knowledge of global safety and pharmacovigilance regulations, guidelines, and industry standards (FDA, EMA, ICH, GVP)

Thorough understanding of Individual Case Safety Reports (ICSR) processing operations, including working with outsourced vendors and Contract Research Organizations

Demonstrated understanding of safety databases, medical literature, and electronic data capture technology

Working knowledge of validated drug safety databases and MedDRA coding dictionary

Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the department or more broadly within Kailera

Adept at communicating the pharmacovigilance and safety vision, effectively aligning activities and performance to achieve functional area goals in alignment with corporate goals

Bachelor's degree or equivalent in Public Health, Life Sciences, or other relevant fields is required