Senior Safety Scientist

Position Overview

• Location Type: Remote
• Job Type: Regular, Full-Time Employee
• Salary: Not provided

Orca Bio is a late-stage biotechnology company focused on redefining the transplant process through next-generation cell therapies. The Senior Safety Scientist will support the development and strengthening of the safety science group by contributing to drug safety and risk management activities across Orca Bio’s clinical programs, aiming to improve survival rates and reduce risks associated with transplants.

Requirements

• Advanced degree in a biologic/medical/clinical/nursing field (e.g., Pharmacist/PharmD, RN/NP, or PhD).
• Minimum of 3-5 years of experience in the biotech/pharmaceutical industry.
• At least 3 years of experience in drug safety, safety science, and risk management.
• Knowledge of US and EU pre- and post-marketing pharmacovigilance requirements.
• Proficiency in analyzing safety data from clinical and safety databases.
• Experience with preparing pre-marketing (e.g., investigational) and post-marketing safety regulatory documents, including DSURs, PSURs, and RMPs.
• Experience with clinical development, risk/benefit analysis.

Responsibilities

• Support signal detection, evaluation, and management, including aggregate data analysis and case-level review, and creating presentations in assigned programs or studies.
• Assist in the development of risk management strategy and activities for both pre- and post-marketed programs, including providing content for RMPs, evaluating risk minimization activities, and preparing responses for regulatory authority safety requests.
• Support safety in clinical trials with review of protocols, SAPs, ICFs, and other clinical documents.
• Lead the planning, preparation, writing, and review of periodic safety reports (e.g., DSUR, PSUR, PBRER) in accordance with regulatory requirements.
• Review AEs/AESIs from clinical trials and provide input on TFLs, listings, and other biometrics outputs.
• Collaborate cross-functionally, representing the PV function in the study team matrix.
• Support the conduct and operation of safety governance, including internal and external safety committees.
• Conduct literature review for assigned programs.
• Support activities related to regulatory filings.
• Support analysis of safety data and writing of safety sections for documents such as CSRs, CSR patient narratives, IBs, RMPs, Summary of Clinical Safety, ISS, and labeling.
• Support inspection preparedness activities and complete any post-audit/inspection deliverables within required timelines.
• Stay abreast of changes in regulations, supporting updates to SOPs.

Application Instructions

• Not provided

Company Information

• Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies.
• Mission: To provide significantly better survival rates with dramatically fewer risks associated with transplants.