Pharmacovigilance Scientist

Pharmacovigilance Scientist

6-month contract

Hybrid in Waltham, MA

We’re seeking a Senior PV Scientist to support safety and risk management activities for investigational and marketed products within an oncology portfolio. This role partners closely with the Safety Physician to evaluate, interpret, and communicate product safety data while ensuring compliance with global regulations.

Key Responsibilities:

• Lead safety analytics and signal management for assigned products
• Author and coordinate aggregate safety reports (DSURs, PSURs, PADERs)
• Review and contribute to clinical and regulatory documents (protocols, IBs, CRFs, ICFs)
• Manage safety queries, data analyses, and health hazard evaluations
• Collaborate cross-functionally with Safety, Biostatistics, Clinical, and Regulatory teams
• Support process improvement initiatives and ensure compliance with PV standards

Qualifications:

• Advanced degree (PharmD, RN, MD, PhD, MPH, NP, or equivalent)
• 5+ years of relevant medical, scientific, or pharmaceutical experience, including 3+ years in pharmacovigilance or drug safety
• Must have experience in mental health or neurology
• Strong analytical, communication, and project management skills
• Proficiency in Excel, PowerPoint, and safety database systems (e.g., Argus)