Pharmacovigilance / Drug Safety Associate

Sutro Biopharma•South San Francisco, CA

16h•Onsite

About The Position

This position offers the opportunity to contribute to the development of Sutro Biopharma’s Pharmacovigilance Operations capability during an important stage of the company’s growth. The individual will gain broad exposure to clinical safety activities and work closely with experienced colleagues across Clinical Development and other functions while helping establish the systems and processes needed to support Sutro’s development programs globally. The successful candidate will embrace Sutro’s collaborative team culture and demonstrate a commitment to quality, scientific rigor, operational excellence, and, above all, patient safety. Position Summary: The Pharmacovigilance / Drug Safety Associate is a key member of the Clinical Development organization and will support Pharmacovigilance (PV) activities across Sutro Biopharma’s portfolio of clinical-stage antibody-drug conjugate (ADC) programs. Reporting to the Executive Director, Pharmacovigilance Operations, this individual will provide hands-on operational support for the collection, processing, review, reconciliation, and reporting of safety information from Sutro-sponsored clinical trials and other applicable sources. The Associate will work closely with Medical Monitors, Clinical Operations, Clinical Development, Regulatory Affairs, Data Management, Quality, external vendors, clinical sites, and development partners to help ensure high-quality and compliant execution of global pharmacovigilance activities. This is an opportunity to join a growing clinical-stage biotechnology company and contribute to the development of scalable PV capabilities, processes, and systems as Sutro’s portfolio advances. The successful candidate will be detail-oriented, collaborative, comfortable working in a dynamic environment, and motivated to help build processes as well as execute them.

Requirements

Bachelor’s degree in a life science, nursing, pharmacy, or related scientific or healthcare discipline; advanced or clinical degree is a plus.
Approximately 2–5 years of experience in pharmacovigilance, drug safety, clinical research, or a related function within biotechnology, pharmaceutical, or CRO environments.
Experience supporting clinical-trial pharmacovigilance and/or safety case processing strongly preferred.
Familiarity with SAE processing, expedited reporting, safety database workflows, and clinical-to-safety database reconciliation preferred.
Working knowledge of relevant pharmacovigilance regulations and guidance, including ICH, GCP, and applicable FDA and global safety reporting requirements.
Experience working with PV vendors, CROs, and/or safety databases is preferred.
Oncology experience is preferred ; experience with antibody-drug conjugates or other oncology therapeutics is a plus.
Experience working in an emerging or clinical-stage biotechnology environment is a plus.
Strong attention to detail with a commitment to data quality and patient safety.
Ability to organize and prioritize multiple activities while meeting time-sensitive regulatory and clinical-study deadlines.
Strong written and verbal communication skills.
Ability to work effectively across functions and with external vendors, partners, and clinical sites.
Sound judgment and ability to recognize and appropriately escalate safety, quality, and compliance issues.
Comfortable working in a fast-paced, evolving environment where processes and infrastructure are being developed and refined.
Proactive, flexible, and willing to take ownership of both routine operational activities and new challenges.
Strong working knowledge of Microsoft Office applications and ability to learn and work effectively with clinical and pharmacovigilance systems.

Nice To Haves

advanced or clinical degree is a plus
Experience supporting clinical-trial pharmacovigilance and/or safety case processing strongly preferred
Familiarity with SAE processing, expedited reporting, safety database workflows, and clinical-to-safety database reconciliation preferred
Experience working with PV vendors, CROs, and/or safety databases is preferred
Oncology experience is preferred
experience with antibody-drug conjugates or other oncology therapeutics is a plus
Experience working in an emerging or clinical-stage biotechnology environment is a plus

Responsibilities

Clinical Safety & Case Management Support the receipt, triage, processing, review, and follow-up of serious adverse events (SAEs) and other reportable safety information from clinical studies in accordance with applicable procedures, study requirements, and global regulations.
Support review of safety cases for completeness, consistency, quality, and appropriate documentation.
Coordinate follow-up activities to obtain missing or clarifying safety information from clinical sites and other sources, as appropriate.
Support the preparation and distribution of expedited safety reports, including SUSARs and other applicable regulatory safety reports, within required timelines.
Assist with SAE reconciliation between the clinical database and global safety database, working closely with Clinical Operations, Data Management, and PV vendors.
Support reconciliation of safety data with other relevant sources, as applicable.
Pharmacovigilance Operations Support day-to-day PV operational activities across Sutro’s clinical development portfolio.
Assist with oversight of PV vendors and service providers, including tracking deliverables, quality metrics, queries, and operational issues.
Support maintenance and use of the global safety database and associated PV systems, including data quality and operational activities.
Assist with development, maintenance, and implementation of PV standard operating procedures (SOPs), work instructions, templates, and other controlled documents.
Maintain PV trackers, metrics, documentation, and other tools used to support compliance and operational oversight.
Support preparation of safety data and documentation for aggregate reports, regulatory submissions, safety reviews, and other clinical development activities.
Assist with PV activities related to partnered development programs, including safety data exchange and reconciliation activities as assigned.
Contribute to the development and continuous improvement of scalable PV processes and infrastructure as Sutro’s clinical portfolio grows.
Cross-Functional Collaboration Partner with Clinical Operations and study teams to support appropriate collection, documentation, and management of safety information from clinical trials.
Participate in study team and cross-functional meetings as the PV Operations representative, as appropriate.
Support development and review of safety-related sections of clinical study documents, including protocols, study manuals, safety management plans, and other study-specific materials.
Assist with safety training for internal teams, clinical sites, vendors, and other stakeholders, as appropriate.
Collaborate with Regulatory Affairs and PV vendors to support timely submission and distribution of required safety information to regulatory authorities, investigators, ethics committees/IRBs, and other recipients.
Work with Quality and other functions to support inspection readiness and responses to audits, inspections, and corrective and preventive actions (CAPAs), as applicable.
Compliance & Quality Perform PV activities in compliance with applicable global regulations, ICH guidelines, Good Pharmacovigilance Practices (GVP), Good Clinical Practice (GCP), company procedures, and study-specific requirements.
Support maintenance of complete, accurate, and inspection-ready PV documentation.
Identify potential quality or compliance issues and escalate them appropriately.
Participate in process improvement initiatives designed to increase the quality, efficiency, and scalability of PV Operations.