Kailera Therapeutics, Inc.
Manager,PharmacovigilanceScientist
“Manager, Pharmacovigilance Scientist at Kailera Therapeutics, Inc.. Skills: Pharmacovigilance, Signal management, Benefit-risk assessment. Support signal management. Benefit-risk assessment”
What You'll Achieve.
Ensure timely and accurate safety data retrieval; Ensure timely and accurate safety data presentation; Ensure timely and accurate safety data analysis; Ensure timely and accurate safety data reporting; Focus on patients’ well-being; Ensure compliance with regulatory requirements; Deliver quality results that meet tight timelines
Industry & Context.
Proactively identify signals, trends, risks
What They're Looking For.
Must Have
6+ years of experience in global pharmacovigilance, Experience in safety data analysis, signal management, benefit-risk evaluation, Knowledge of safety databases (Argus, ArisG/LifeSphere Safety, Veeva or similar), ICSR workflows, 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, Ability to prioritize, multitask, and deliver quality results, Fluency in written and spoken English
Nice to Have
Prior experience with contributing to clinical study or regulatory submission documents, Knowledge of drugiologics 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
What You'll Do.
Support signal management
Benefit-risk assessment
Safety surveillance activities
Perform benefit-risk assessment
Perform safety signal management
Author signal validation/evaluation reports
Track and communicate findings
Contribute to safety governance
Provide pharmacovigilance input
Contribute to medical literature monitoring
Support safety physicians
Manage aggregate safety reports
Review emerging safety data
Retrieve and present data
Utilize data visualization tools
Prepare Risk Management Plans
Author safety sections
Provide safety surveillance expertise
Prepare safety sections
Support audits/inspections
Contribute to safety responses
Respond to deviations
Support preparation of procedural documents
Contribute to Business Continuity Plan
Provide content for training
Implement technical solutions
Improve safety surveillance capabilities
How You'll Work.
Team & Collaboration
Collaborate cross-functionally; Collaborate with cross-functional teams; Collaborate with internal and external partners
Communication Scope
Communicate complex issues clearly
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