[Remote] Scientist, Pharmacovigilance
Note: The job is a remote job and is open to candidates in USA. Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. They are seeking a Pharmacovigilance Scientist to support drug safety activities across early-phase clinical programs, overseeing vendor-delivered case processing and ensuring compliance with global safety requirements.
Responsibilities
- 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. Skills
- 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 PV requirements (ICH, FDA, EMA, CIOMS, TGA) with practical application in early-phase clinical studies.
- Strong analytical and written communications skills, 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 bolthires Office tools.
Benefits
- Competitive salary
- Bonus
- Equity
- 20 vacation days
- 5 sick days
- Technology allowance
- Commuter reimbursement
- Generous retirement savings plans with employer matching
- Extended health benefits
- Paid holidays Company Overview
- Alpha-9 Oncology is a clinical stage, radiopharmaceutical company developing differentiated and highly targeted radiopharmaceuticals with the potential to meaningfully improve the treatment of people living with cancer. It was founded in 2019, and is headquartered in Vancouver, British Columbia, CAN, with a workforce of 51-200 employees. Its website is Apply tot his job Apply tot his job Apply tot his job Apply tot his job Apply tot his job Apply tot his job
Apply tot his job Apply To this Job Apply tot his job Apply To this Job