Pharmacovigilance Scientist

Oruka Therapeutics Inc; Waltham (MA); Hybrid; USD 130,000 - 161,000; Full time

Benefits offered by this job

Vibrant startup culture

Competitive salary

Inclusive team environment

Growth opportunities

Job summary

Oruka Therapeutics Inc. seeks a Pharmacovigilance Scientist to lead safety data collection, review, and signal detection across clinical development.

The role collaborates with clinical operations, regulatory, and medical affairs to safeguard patient safety and regulatory compliance. The candidate will prepare DSURs, dRMPs, and regulatory submissions while maintaining knowledge of pharmacovigilance regulations and industry standards.

Qualifications

• 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.

Responsibilities

• Collects, analyzes adverse event reports to identify potential safety signals.
• Supports safety data management activities, including case processing, follow-up, and coding of adverse events.
• Assists in risk assessments and development of risk mitigation strategies.
• Prepares and reviews pharmacovigilance documents such as DSURs, dRMPs, and regulatory submissions.
• Maintains current knowledge of relevant therapeutic areas, pharmacology, and drug safety regulations.
• Collaborates with cross-functional teams to ensure comprehensive safety oversight and vendor oversight.

Skills

Analytical skills

Communication skills

Presentation skills

Organizational skills

Project management

Collaboration

Education

PharmD or PhD in life sciences

Tools

Argus

MedDRA

Veeva Vault

Job description

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. For more information, visit www.orukatx.com

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 or Hybrid if commutable to office in Waltham, MA employee will be required to be in-office 3 days/week.

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.

Key Responsibilities

• 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.

Qualifications

• 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

Compensation

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, Scientist I is $130,000-146,000 and Scientist II is $146,000-161,000 . The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.
• If located within one of our offices in Waltham, MA or Menlo Park, CA, you will be required to go into office 3 days a week.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

Salary Range for the Role: $130,000 USD - $161,000 USD

What We Offer

• 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.