Overview Associate Director, Pharmacovigilance Scientist role at Kailera Therapeutics. The Associate Director will provide leadership, guidance, and support to signal management, benefit-risk assessment, and other safety surveillance activities globally for assigned Kailera products throughout their lifecycle, with focus on patient well-being and regulatory compliance. The role involves cross-functional collaboration to ensure timely and accurate safety data retrieval, presentation, analysis, and reporting. Location Required location: Waltham, MA (onsite or hybrid 2-3 days per week). Responsibilities Perform and coordinate benefit–risk assessment and safety surveillance activities Support the safety governance framework, prepare safety data for review, and coordinate/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 trend analysis and signal detection as applicable Contribute to the preparation of queries in the safety database and retrieve/present data for regular and ad-hoc safety reviews Perform safety signal management activities; conduct signal detection, author signal validation/evaluation reports, and communicate findings Collaborate 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 safety sections of clinical trial documents (e.g., IB, Protocols, ICFs, CSRs) as needed Contribute to the preparation of safety sections of regulatory submission modules Represent DSPV on audits/inspections and contribute to safety responses as needed Contribute to responses to deviations and CAPAs related to pharmacovigilance Lead and contribute to the preparation and implementation of procedural documents as applicable to pharmacovigilance Contribute 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 Required Qualifications 5-7 years of global pharmacovigilance experience in pharmaceutical, biotech, or CRO settings 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 and signal assessment reports Working knowledge of local and global regulatory requirements and guidance documents Experience 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 with internal and external partners in a demanding environment Ability to prioritize, multitask, and deliver quality results to tight timelines Fluent in written and spoken English with ability to communicate complex issues clearly Preferred Qualifications Experience contributing to clinical study or regulatory submission documents Knowledge of drug/biologics development process Experience with health authority pharmacovigilance inspections Education Advanced degree (PharmD, MS, NP, RN) or equivalent in pharmacy, nursing, healthcare or related life sciences; MD or PhD is a plus Salary Salary Range: $160,000—$200,000 USD Benefits Comprehensive health benefits and tax-advantaged savings accounts Flexible time off, 13 paid holidays, and a companywide year-end shutdown Monthly wellness stipend Generous 401(k) match Disability and life insurance Equal Employment Opportunity Information Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender, gender identity or expression, sexual orientation, marital status, military service or veteran status, disability, genetic information, reproductive health decisions, or any other characteristic protected by law. E-Verify Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires. Seniority level Mid-Senior level Employment type Full-time Job function Business Development and Sales Referrals increase your chances of interviewing at Kailera Therapeutics. Get notified about new Associate Director jobs in Greater Boston.

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