Pharmacovigilance Scientist (Fully Remote)

Oruka Therapeutics Inc; United States; Hybrid; USD 130,000 - 161,000; Full time

Benefits offered by this job

Equity

Performance bonus

Remote or hybrid work to Waltham, MA

Job summary

Oruka Therapeutics is developing novel biologics aimed at treating chronic skin diseases, building a core team for a startup culture.

The Pharmacovigilance Scientist will collect, review, and analyze adverse event reports, support safety monitoring, and prepare DSURs and regulatory submissions, collaborating closely with the Senior Medical Director to drive pharmacovigilance strategy.

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.

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.

Skills

GVP knowledge

Regulatory awareness

Education

PharmD/PhD

Tools

Argus

MedDRA

Veeva Vault

Job description

• 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.

Oruka Therapeutics

Oruka Therapeutics is developing novel biologics designed to set a new standard for treating chronic skin diseases like plaque psoriasis. They are an early-stage public company (Nasdaq: ORKA) building a core team, seeking top talent to contribute to an engaged, inclusive, and positive culture.