Senior Safety Scientist

Summary

Join Orca Bio, a late-stage biotechnology company revolutionizing blood cancer treatment, as a Senior Safety Scientist. You will play a crucial role in strengthening the safety science group, supporting drug safety and risk management across clinical programs. Key responsibilities include signal detection and evaluation, risk management strategy development, and preparation of periodic safety reports. This position requires an advanced degree in a relevant field, extensive experience in drug safety and risk management, and strong analytical and communication skills. Orca Bio is driven by a passion for science and compassion for patients, fostering a collaborative and entrepreneurial work environment.

Requirements

• Advanced degree in a biologic/medical/clinical/nursing field, such as Pharmacist/PharmD, RN/NP, or PhD
• Minimum of 3-5 years of experience in the biotech/pharmaceutical industry with 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
• Experience with analysis of safety data from clinical and safety databases
• Proficiency in preparing pre-marketing (eg, investigational) and post marketing safety regulatory documents, including DSURs, PSURs and RMPs
• Experience with clinical development, risk/benefit analysis, and signal detection
• Strong clinical, analytical, problem-solving, scientific writing, and communication skills
• Hands-on mentality, ability to operate with limited resources

Responsibilities

• Support signal detection, evaluation and management, including conducting 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 (eg, 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