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Kailera Therapeutics · 3 months ago

Associate Director, Pharmacovigilance Scientist

Waltham, Massachusetts

Full-time

Onsite

Senior Level

$160K/yr - $200K/yr

5+ years exp

Kailera is committed to developing therapies that empower individuals to transform their lives and improve their health. They are seeking an Associate Director, Pharmacovigilance Scientist to lead safety surveillance activities and benefit-risk assessments for their products, ensuring compliance with regulatory requirements. This role involves collaboration across functions to manage safety data and contribute to safety-related documentation and training.

BiotechnologyPharmaceuticalTherapeutics

Responsibilities

Perform and coordinate benefit-risk assessment and safety surveillance activities

Support the safety governance framework, prepare safety data for review, coordinate and attend Safety Management Team and Medical Safety Board meetings

Coordinate and support strategies for safety assessments in collaboration with the safety physician and medical development as applicable

Lead and contribute to the management of aggregate safety reports (e.g., DSURs, PBRERs, PADERs, periodic line listings) including scheduling, planning, and authoring assigned sections

Collaborate with cross-functional teams to regularly review emerging safety data for the purposes of trend analysis and/or signal detection as applicable

Contribute to the preparation of queries in the safety database, retrieve and present data for regular and ad-hoc safety reviews

Perform safety signal management activities; conduct signal detection, author signal validation/evaluation reports, track and communicate findings

Collaborate cross functionally to access and utilize data visualization and analysis tools for regular and ad-hoc safety reviews

Lead or assist with the preparation of Risk Management Plans (RMPs)

Contribute to responses to drug safety related health authority requests

Provide input into the safety sections of clinical trial documents (e.g., IB, Protocols, ICFs, CSRs) as needed

Contribute to the preparation of the safety sections of regulatory submission modules

Represents DSPV on audits/inspections and contributes to safety responses as needed

Contribute to responses to deviations and CAPAs as related to pharmacovigilance

Lead and actively contribute to the preparation and implementation of procedural documents as applicable to pharmacovigilance

Contribute as needed to the Global DSPV Business Continuity Plan

Provide content for pharmacovigilance training as needed

Contribute to the implementation of innovative technical or procedural solutions to improve DSPV safety surveillance capabilities

Other responsibilities as assigned

Qualification

Global pharmacovigilance experienceSafety data analysisSignal managementSafety databases knowledgeRegulatory requirements knowledgeAggregate safety reports authoringMultitaskProactive signal identificationCommunication skillsCollaborative work

Required

A minimum of 5-7 years of experience in global pharmacovigilance in pharmaceutical, biotech, or CRO setting

Experience in safety data analysis, signal management, and benefit-risk evaluation

Knowledge of safety databases (Argus, ArisG/LifeSphere Safety, Veeva or similar), ICSR workflows, and MedDRA coding

Experience with authoring or contributing to aggregate safety reports, signal assessment reports

Working knowledge of relevant local and global regulatory requirements and guidance documents

Experience in creating or managing SOPs or Work Instructions

Strong ability to proactively identify signals, trends, risks, and initiate/manage risk minimization activities

Strong ability to work independently and collaboratively with internal and external partners in a demanding environment

Ability to prioritize, multitask, and deliver quality results that meet tight timelines

Fluency in written and spoken English with strong ability to communicate complex issues clearly

Advanced degree (PharmD, MS, NP, RN) or equivalent in pharmacy, nursing, healthcare or other related life sciences field is required. MD or Ph.D. degree is a plus