Kailera Therapeutics, Inc.

Manager, Pharmacovigilance Scientist

Waltham, Massachusetts · Full-time

Sponsorship not specified$127k-$155kDetected 15 days ago

Machine LearningData AnalysisData VisualizationFDA RegulatoryPharmacovigilanceCollaboration

About the role

As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
Salary Range $127,000 - $155,000 USD For Full Time Roles: This range represents the company's good-faith estimate of the salary at the time of posting.
Actual pay may vary based on experience, skills, qualifications, location, and internal equity.

Provide pharmacovigilance input into core safety documents including Reference Safety Information (RSI) updates
Support and collaborate with safety physicians on safety review strategies
Collaborate with cross-functional teams to regularly review emerging safety data for the purposes of trend analysis and/or signal detection as applicable
Collaborate cross functionally to access and utilize data visualization and analysis tools for regular and ad-hoc safety reviews
Collaborate cross-functionally to ensure timely and accurate safety data retrieval, presentation, analysis, and reporting.
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
Support the preparation and implementation of pharmacovigilance procedural documents

A minimum of 6+ years of experience in global pharmacovigilance in pharmaceutical, biotech, or CRO setting
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
Experience in creating or managing SOPs or Work Instructions
Fluency in written and spoken English with strong ability to communicate complex issues clearly

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 EMA and FDA pharmacovigilance regulatory frameworks
Advanced degree strongly preferred
Bachelors degree in life sciences

$127,000 - $155,000 USD
For Full Time Roles: This range represents the company's good-faith estimate of the salary at the time of posting.
Actual pay may vary based on experience, skills, qualifications, location, and internal equity.
Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants-because your well-being and future matter to us.
This range represents the company's good-faith estimate of the salary at the time of posting.

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.
Advanced degree (PharmD, MS, NP, RN) or equivalent in pharmacy, nursing, health care or other related life sciences field is preferred.
We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown.

We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence.

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

tive hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-rel

This listing is sourced directly from Kailera Therapeutics, Inc.'s careers page and normalized into a canonical job model.