Associate Director, Pharmacovigilance Scientist Jobs

Kailera Therapeutics

Location:
United States, Waltham

Category:
Research and Development

Contract Type:
Not provided

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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Associate Director, Pharmacovigilance Scientist