Pharmacovigilance Scientist

Summary

Oruka Therapeutics is developing novel biologics for the treatment of chronic skin diseases, including plaque psoriasis and other dermatologic and inflammatory diseases. The Pharmacovigilance Scientist supports the collection, evaluation, and management of drug safety data throughout clinical development, including adverse event review, signal detection, risk management, safety documentation, and cross-functional pharmacovigilance activities.

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

Skills

• 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

Qualifications

Must Haves

• 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

• Equity
• A performance-related bonus opportunity
• Remote work, or hybrid work if commutable to the Waltham, MA office
• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
• Opportunities for professional growth and development