Remote Pharmacovigilance Scientist — High-Impact Safety

Openkrill; United States; Hybrid; USD 130,000 - 161,000; Full time

Benefits offered by this job

Competitive salary

Equity

Professional growth

Job summary

Oruka Therapeutics is seeking a Pharmacovigilance Scientist to drive safety data collection, evaluation, and risk management across clinical development. You will work with cross-functional teams to ensure regulatory compliance and high-quality safety documentation.

The role involves monitoring adverse events, identifying safety signals, and contributing to DSURs, dRMPs, and regulatory submissions. Remote or hybrid work options available with in-office requirements in Waltham, MA schedule.

Qualifications

• Advanced degree in life sciences (PharmD/PhD).
• 3+ years in pharma with drug safety experience preferred.
• Knowledge of pharmacovigilance practices, regulations, and clinical trial processes.
• Experience with adverse event data review and safety database systems.

Responsibilities

• Collect, review and analyze adverse event reports from trials to detect safety signals.
• Support ICSR quality control and data reconciliation activities.
• Assist in safety data management including case processing and coding of events.
• Prepare safety documents like DSURs and RM plans under guidance.
• Collaborate with cross-functional teams to ensure safety oversight.
• Support aggregation reports, safety meetings, and vendor oversight.

Skills

Pharmacovigilance

Safety data review

Communication skills

Project management

Cross-functional collaboration

Education

PharmD

PhD

Life sciences master's

Tools

Argus

MedDRA

Veeva Vault

Job description

Oruka Therapeutics is seeking a Pharmacovigilance Scientist to drive safety data collection, evaluation, and risk management across clinical development. You will work with cross-functional teams to ensure regulatory compliance and high-quality safety documentation.

The role involves monitoring adverse events, identifying safety signals, and contributing to DSURs, dRMPs, and regulatory submissions. Remote or hybrid work options available with in-office requirements in Waltham, MA schedule.