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.
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. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. 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.
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