Pharmacovigilance Scientist

Remote;
Waltham, Massachusetts, United States

About Us:

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases.

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As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.

Job Title: Pharmacovigilance Scientist

Location: Remote

Role Overview:

The Pharmacovigilance Scientist plays a critical role in the collection, evaluation, and management of drug safety data throughout clinical development. This role supports the monitoring and assessment of adverse events, safety signal detection, and risk management activities to safeguard patient safety and ensure regulatory compliance. The Pharmacovigilance Scientist collaborates with cross-functional teams to maintain the integrity of safety data and contributes to the preparation of safety-related documentation, presentations and aggregate reports.

They work closely with the Senior Medical Director, Pharmacovigilance and Safety, to execute pharmacovigilance strategies.

• Safety Data Collection and Review:
  • 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
• Risk Assessment and Signal Detection:
  • 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
• Pharmacovigilance Documentation:
  • 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)
• Scientific Expertise:
  • Maintains current knowledge of relevant therapeutic areas, pharmacology, and drug safety regulations
  • Conducts literature reviews and safety signal assessments to inform safety evaluations
• Cross-Functional Collaboration:
  • 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.

• Advanced degree in life sciences (e.g., Pharm
  
  D, 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…