Pharmacovigilance Scientist

Role Overview:

• The Pharmacovigilance Scientist plays a critical role in safety data collection, evaluation, and management.
• Supports safety signal detection, risk management, and regulatory compliance.
• Collaborates closely with the Senior Medical Director to execute pharmacovigilance strategies.

Key Responsibilities:

• Collects, reviews, and analyzes adverse event reports from clinical trials.
• Supports quality control of individual case safety reports and ongoing safety monitoring.
• Prepares safety documentation including DSURs, dRMPs, and regulatory submissions.

Qualifications:

• Advanced degree in life sciences (PharmD, PhD) with minimum 3 years pharma experience.
• Knowledge of GVP, CIOMS, EMA, ICH, and FDA guidelines.
• Experience with safety databases like Argus, MedDRA, and Veeva Vault.

Compensation:

• Salary range $130,000-$161,000 USD plus equity and performance bonus.
• Remote or hybrid work option if commutable to Waltham, MA office.
• Opportunity to be part of a vibrant startup culture with professional growth.