Drug Safety Associate

More 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 commercial-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 cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

Summary:

• Responsible for reviewing adverse events and assisting in the determination of regulatory reporting for assigned investigational products
• May serve as a liaison to internal and external stakeholders for AE reporting issues (i.e. site staff, CRAs, case processing vendor)
• Works in collaboration with other functional groups such as data management, clinical operations, regulatory affairs, quality, and medical affairs

Key Responsibilities:

• Serves as the main point of contact for any adverse event questions, requests, and/or reviews within the safety and clinical databases
• Initial review of incoming initial and follow up SAE/AESI reports and issues clinically appropriate queries as needed
• Perform quality control checks and finalization step for each case entered in the Argus database
• Assists in the day-to-day oversight of the case processing vendor including the monitoring of KPIs for vendor assessment
• Serves as the point of contact for any issues noted in the safety database and generates Help Desk tickets when appropriate
• Assists in the preparation of safety reports to be submitted to regulatory agencies
• Assists with literature review, as required
• Evaluation of existing data points and generation of follow-up queries for all reports within protocol specified timelines
• Ensures consistency in the evaluation and assessment of AE reports for completeness, accuracy and legibility for case entry
• Exercises judgement and use of knowledge of FDA and ICH guidelines in performing case reviews
• Contributes to coding of medical terms, procedures, and concomitant medications in a consistent and timely manner
• Maintains contemporaneous status within the eTMF as it relates to relevant safety communications and documents
• Generate scheduled reports from the safety database to share with clinical team as well as fulfilling any ad hoc requests
• Provide subject matter expertise on adverse events
• Attends and contributes to internal meetings as appropriate for role
• Assists in various projects as assigned by direct supervisor and/or PV department leadership
• Review and create study related documents such as Safety Management Plans , safety summaries, and SAE reconciliation

Required Qualifications

• A minimum degree of bachelor's or higher degree in a clinical or closely related field
• 2-3 years of related experience gained in a biotech or pharmaceutical company
• 1-2 years of experience in cellular therapy, stem cell transplant, and/or oncology strongly preferred
• Post-marketing experience desirable
• Proficiency in the Argus safety database system
• Working knowledge of MedDRA and WHODrug coding preferred
• Veeva Vault experience preferred
• Excellent written and verbal communication skills
• Strong attention to detail
• Excellent organizational and prioritization skills
• Ability to work independently and in a team setting
• Ability to manage day-to-day operations as well as special projects within a growing company
• Fluent in medical terminology, preferred

The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.