Manager, Pharmacovigilance Scientist

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, MS, NP, RN) or equivalent in pharmacy, nursing, health care or other related life sciences field is preferred.