Associate Director, Safety Scientist
About The Position
We are seeking a skilled and versatile Associate Director, Safety Scientist to join our growing Drug Safety team. This critical role provides scientific expertise for medical safety tasks. Core responsibilities include safety data review and analysis from different sources, periodic report authoring and the oversight of the safety surveillance activities for the assigned program(s). The successful candidate will bring hands-on pharmacovigilance experience, a strong understanding of global safety regulations, and a proactive approach to cross-functional collaboration. This position is ideal for a PV professional looking to expand their scope and impact in a dynamic biotech environment. This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.
Requirements
- Advanced degree (PharmD, PhD, MD, or MS) in a life sciences discipline, or equivalent scientific background is required.
- 4+ years of experience in pharmacovigilance or clinical development within a pharmaceutical or biotechnology company.
- Familiarity with global pharmacovigilance regulations (FDA, EMA, ICH, CIOMS) and safety databases (e.g., Argus, ArisGlobal).
- Expertise with Microsoft Word, PowerPoint, SharePoint and Excel
- Excellent written and verbal communication skills, with a track record of high-quality safety document contributions.
- Ability to collaborate effectively across functions, drive timelines, and maintain compliance standards.
Responsibilities
- Perform cumulative safety data reviews across trials or indications to assess safety profiles and identify emerging risks or trends
- Responsible for review of aggregate safety data and signal management, including signal detection, signal investigation, and preparation of signal evaluation reports, including input into a design of a comprehensive safety surveillance system.
- Collaborate with Safety Physicians to review and align on safety data conclusions for informed decision-making regarding assigned program(s)
- Lead preparation of aggregate safety reports (e.g., DSURs) from kick-off to submission to applicable health authorities
- Provide input into regulatory submissions (e.g., BLA, Module 2.7.4/2.5) and respond to Health Authority queries with scientifically sound responses
- Contribute or be the primary safety contact person for clinical trial-related documents including Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Statistical Analysis Plans (SAPs), and eCRF setup
- Mentor new team members by providing training on core safety processes and fostering their development within the organization
- Act as Subject Matter Expert during audits and inspections for key safety processes such as Safety Surveillance and aggregate report generation
- Lead the safety governance meetings and develop meeting materials (agenda, minutes, slide preparation)
- Additional activities as assigned at the discretion of the hiring manager
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
11-50 employees
