United States onlyMore than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
The Senior Safety Scientist will help develop and strengthen the safety science group by supporting drug safety and risk management activities across Orca Bio's clinical programs.
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
Qualifications
- 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.
Who we are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
