Manager, Pharmacovigilance Scientist

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.

What You will Do:

The Manager, Pharmacovigilance Scientist will provide support to signal management, benefit-risk assessment, and other safety surveillance activities globally for assigned Kailera products throughout their lifecycle with focus on patients’ well-being and compliance with applicable regulatory requirements. Collaborate cross-functionally to ensure timely and accurate safety data retrieval, presentation, analysis, and reporting.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

Perform and coordinate complex benefit-risk assessment and safety surveillance activities. Perform safety signal management activities; conduct signal detection, author signal validation/evaluation reports, track and communicate findings

Serve as a contributor to the safety governance framework, prepare safety data for review at Medical Safety Board meetings

Provide pharmacovigilance input into core safety documents including Reference Safety Information (RSI) updates

Contribute to medical literature monitoring activities and review of relevant publications for potential safety signals

Support and collaborate with safety physicians on safety review strategies

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

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

Contribute to the preparation of Risk Management Plans (RMPs)

Author responses to health authority requests in collaboration with safety physicians

Support safety physicians on authoring the safety sections of clinical trial documents (e.g., IB, Protocols, ICFs, CSRs) as needed. Provide safety surveillance expertise throughout the study lifecycle

Support safety physicians on the preparation of the safety sections of regulatory submission modules

Support audits/inspections and contribute to safety responses as needed

Contribute to responses to deviations and CAPAs as related to pharmacovigilance

Support the preparation and implementation of pharmacovigilance procedural documents

Contribute as needed to the Global PSPV Business Continuity Plan

Provide content for pharmacovigilance training as needed

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

Other responsibilities as assigned

Required Qualifications:

A minimum of 6+ 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

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

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

Preferred Qualifications:

Prior experience with contributing to clinical study or regulatory submission documents

Knowledge of drug/biologics development process

Experience in a startup or small biotech environment

Experience with obesity, metabolic, or cardiometabolic therapeutic areas

Familiarity with AI/ML applications in pharmacovigilance signal detection

Experience with health authority pharmacovigilance inspections

Experience with EMA and FDA pharmacovigilance regulatory frameworks

Advanced degree strongly preferred

Education:

Bachelors degree in life sciences

Advanced degree (PharmD, M…