Oruka Therapeutics · 1 month ago
Pharmacovigilance Scientist
United States
Full-time
Remote
Mid Level
$125K/yr - $155K/yr
3+ years expOruka Therapeutics is developing novel biologics for chronic skin diseases and is seeking a Pharmacovigilance Scientist to manage drug safety data throughout clinical development. The role involves monitoring adverse events, ensuring regulatory compliance, and collaborating with cross-functional teams to maintain safety data integrity.
BiotechnologyHealth CareMedical
Responsibilities
Collects, reviews, and analyzes adverse event reports from clinical trials to identify potential safety signals
Supports quality control review of individual case safety reports (ICSRs)
Assists in ongoing safety monitoring activities, including data reconciliation and quality checks to ensure accuracy of safety data
Supports safety data management activities, including case processing, follow-up, and coding of adverse events
Assesses clinical safety data to identify, evaluate, and document adverse events and emerging safety concerns
Contributes to risk-benefit analyses and supports the development of risk mitigation strategies
Supports the preparation and review of pharmacovigilance documents such as Development Safety Update Reports (DSURs), development Risk Management Plans (dRMPs), and relevant sections of clinical trial protocols, IBs and regulatory submissions
Proficient with safety surveillance systems and tools (e.g., Argus, MedDRA, Veeva Vault)
Maintains current knowledge of relevant therapeutic areas, pharmacology, and drug safety regulations
Conducts literature reviews and safety signal assessments to inform safety evaluations
Works closely with clinical operations, regulatory affairs, medical affairs, data management, bioinformatics and project management teams to ensure comprehensive safety oversight
Supports compliance with global pharmacovigilance regulations and company safety policies
Supports the communication and oversight of pharmacovigilance and contract research organization vendors
Supports the project management of safety activities such as aggregate reports, safety team meetings, signal evaluations, etc
Qualification
Required
Advanced degree in life sciences (e.g., PharmD, PhD) or related field
Minimum of 3 years of experience within the pharmaceutical industry, ideally including drug safety experience
Knowledge of good pharmacovigilance practices, drug safety regulations, and clinical trial processes
Understanding of pharmacovigilance regulatory practices including CIOMS, EMA, ICH and FDA guidelines
Experience with adverse event data review, safety signal detection, and safety database management (e.g. Argus, MedDRA, Veeva Vault)
Strong analytical, communication and presentation skills
Strong organizational and project management skills
Ability to collaborate effectively across multidisciplinary teams in a fast-paced environment
Benefits
A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
Competitive salary and benefits package.
A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
Opportunities for professional growth and development.
Company
Oruka Therapeutics
Oruka Therapeutics is advancing innovative biologics to redefine patient care standards in chronic skin diseases.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$455MKey Investors
Viking Global Investors
2025-09-17Post Ipo Equity· $180M
2024-09-03Post Ipo Equity· $275M
2024-09-03IPO
Recent News
2025-12-12
Oruka Therapeutics, Inc.
2025-11-13
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