Senior Safety Scientist (Boston)

Senior Clinical Safety Scientist

The Senior Clinical Safety Scientist is responsible for leading proactive safety surveillance activities for investigational medicinal products evaluated in interventional clinical studies. This role serves as a key point of contact for project teams and external partners on all safety-related matters and collaborates closely with Clinical Safety Physicians on scientific and medical safety aspects of clinical programs.

Key Responsibilities

• Support Clinical Safety Physicians with safety-related tasks across prescription (Rx) products in development, including global Phase I-IV and regional interventional studies.
• Contribute to post-marketing safety activities following regulatory approval.
• Conduct signal detection, validation, and evaluation activities as directed, and present safety observations or analyses in safety review meetings.
• Contribute to the preparation of aggregate safety reports such as DSURs, PSURs, and PBRERs for investigational products.
• Assist with regulatory dossier submissions, including Clinical Overviews, Clinical Evaluation Reports, and Summaries of Clinical Safety.
• Provide input on updates to the Investigator's Brochure, particularly the Reference Safety Information.
• Review safety sections of study protocols and informed consent forms (ICFs).
• Review and update safety content in Clinical Study Reports and related publications.
• Represent Clinical Safety in study team meetings and collaborate with internal and external stakeholders to ensure timely delivery of safety-related milestones.
• Provide input into Safety Data Exchange Agreements and Study Safety Management Plans.
• Contribute to the development and review of departmental quality documents, such as SOPs and working guidelines.