Associate Director, Pharmacovigilance Scientist

Kailera Therapeutics, Inc. • Waltham, MA

133d • $160,000 - $200,000

About The Position

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.

Requirements

• 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

Nice To Haves

• Prior experience with contributing to clinical study or regulatory submission documents
• Knowledge of drug/biologics development process
• Experience with health authority pharmacovigilance inspections

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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Master's degree