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Associate Director, Pharmacovigilance Scientist

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Kailera Therapeutics

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Location:
United States , Waltham

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

160000.00 - 200000.00 USD / Year
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Job Description:

The Associate Director, Pharmacovigilance Scientist 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 patients’ well-being and compliance with applicable regulatory requirements. Collaborate cross-functionally to ensure timely and accurate safety data retrieval, presentation, analysis, and reporting.

Job Responsibility:

  • Perform and coordinate complex benefit-risk assessment and safety surveillance activities
  • Serve as a critical contributor to 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

Requirements:

  • A minimum of 10+ years of experience in global pharmacovigilance in pharmaceutical, biotech, or CRO setting with a Bachelors degree or 5+ years of experience with an advanced degree
  • 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
  • Bachelors degree in life sciences
  • Advanced degree (PharmD, MS, NP, RN) or equivalent in pharmacy, nursing, health care or other related life sciences field is required. MD or Ph.D. degree is a strong plus

Nice to have:

  • Prior experience with contributing to clinical study or regulatory submission documents
  • Knowledge of drug/biologics development process
  • Experience with health authority pharmacovigilance inspections
  • Advanced degree strongly preferred
What we offer:
  • 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

Additional Information:

Job Posted:
December 09, 2025

Employment Type:
Fulltime
Work Type:
Hybrid work
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