What are the responsibilities and job description for the Scientist, Pharmacovigilance position at Alpha 9 Oncology?
Your Impact
Alpha-9 Oncology is seeking a Pharmacovigilance Scientist to support drug safety activities across our early-phase clinical programs. You will establish foundational processes and operations, oversee vendor-delivered case processing, and ensure compliance with global safety requirements. This hands-on role offers the opportunity to shape how PV operations are built and scaled in a growing clinical stage radiopharmaceutical company.
How You'll Contribute
- Serve as the internal lead for PV operations, partnering with CROs, internal and external medical safety experts to ensure timely and accurate case processing, reconciliation, and safety reporting.
- Manage the collection, review, and quality oversight of safety data from clinical trials, including expedited and periodic reporting to regulatory authorities.
- Conduct and document literature surveillance and aggregate safety data review to identify potential safety signals.
- Support development of safety sections of regulatory documents (e.g., investigator brochures, DSURs, clinical study reports).
- Maintain inspection-ready safety documentation and contribute to the authoring and updating of PV SOPs and work instructions.
- Collaborate with Clinical Operations, Regulatory Affairs, and Quality to align safety processes with overall program execution.
- Contribute to vendor oversight, including review of safety deliverables, metrics, and compliance reports.
The Skills You Bring
- Advanced degree (PharmD, RN, Ph.D., MPH, or MS) in a scientific or health-related field.
- 3 years of pharmacovigilance experience in biotech, pharma, or CRO settings.
- Hands-on experience with case processing, safety data reconciliation, and aggregate report contributions.
- Knowledge of global PB requirements (ICH, FDA, EMA, CIOMS, TGA) with practical application in early-phase clinical studies.
- Strong analytical and written communications kills, with the ability to synthesize and interpret safety data.
- Experience with CROs and vendors in a lean, fast-paced, early-stage biotech environment.
- Familiarity with safety databases and Microsoft Office tools.
What's in it for you
At Alpha-9 Oncology, we offer a competitive and comprehensive benefits package designed to support all employees. Our benefits include a competitive salary, bonus, equity, 20 vacation days, 5 sick days, a technology allowance, and commuter reimbursement. We also provide generous retirement savings plans with employer matching, extended health benefits, and paid holidays, tailored to local standards in each region. While specific offerings may vary by location, our commitment to fostering a supportive and rewarding work environment is consistent across the company.
Company Summary
Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. Our proprietary scaffolds, composed of optimized binders, linkers, chelators, and radioisotopes, enable targeted radiation delivery to cancer cells, minimizing harm to surrounding healthy tissue. Focusing on innovative targeting moieties, we develop molecules tailored for precise tumor targeting.
Our comprehensive platform integrates imaging and therapeutic studies to ensure effective radiation delivery and improved patient outcomes. With a robust pipeline entering clinical trials and strong support from leading healthcare investors, Alpha-9 is positioned for rapid growth and advancement in cancer therapy.
More about Alpha-9 Oncology
Alpha-9 Oncology is committed to fostering a diverse and inclusive workplace and is proud to be an Equal Opportunity Employer. We provide employment opportunities to all qualified applicants without regard to race, ethnicity, religion, age, sex, gender identity or expression, sexual orientation, disability, marital status, family status, national origin, or any other characteristic protected by applicable federal, provincial, or local laws where we operate.
We are dedicated to providing reasonable accommodations to qualified applicants and employees to ensure that everyone can perform their essential job functions in an inclusive environment. For inquiries regarding accommodations in the hiring process or for current employees, please contact a member from our Talent Acquisition team.