Clinical Safety Scientist

Job Title : Clinical Safety Scientist

Location : Onsite in Waltham, MA (3 days per week)

Experience : 5+ years

Duration : 12+ months contract with strong potential for extension Overview

We're seeking an experienced Clinical Safety Scientist to lead safety surveillance and risk management activities for both investigational and marketed products. This role is key to ensuring the integrity and accuracy of safety data, working closely with the Safety Physician / Medical Monitor and cross-functional teams to meet global pharmacovigilance requirements.

Key Responsibilities

Lead and manage ongoing safety surveillance, signal validation, and aggregate reporting (PSUR, PADER, DSUR)

Conduct literature reviews and prepare materials for safety governance meetings

Handle ad hoc safety queries and regulatory authority requests

Support clinical development activities, including IB updates, DSMB presentations, CRF / ICF development, and safety narratives

Ensure compliance with evolving global pharmacovigilance regulations, SOPs, and internal quality standards

Required Qualifications

Minimum 3+ years of experience as a Pharmacovigilance Scientist

Minimum 5+ years in pharmaceutical, medical, or clinical research roles

Advanced degree preferred : PharmD, RN, MD, PhD, MPH, or NP

Strong analytical and writing skills with proficiency in Excel

Background in mental health or neurology therapeutic areas

Preferred / Bonus Skills

Familiarity with MedDRA , Argus Safety , and safety database systems

Strong project management, communication, and leadership skills

Ability to work both independently and collaboratively within multidisciplinary teams