Senior Manager, Drug Safety

BLOSSOMHILL THERAPEUTICS INC•San Diego, CA

7d•$165,067 - $204,228•Onsite

About The Position

The Senior Manager, Drug Safety will play a key role in supporting the company’s drug safety and pharmacovigilance activities. This hands-on role will provide clinical, scientific, and operational expertise in the identification, assessment, documentation, and management of safety information arising from clinical trials. The successful candidate will have progressive, hands-on drug safety/pharmacovigilance experience and a strong understanding of clinical safety principles, global regulatory requirements, safety surveillance, and outsourced pharmacovigilance operations. The role will collaborate closely with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Data Management, and other cross-functional teams to ensure timely, compliant, and high-quality safety assessment and reporting. The ideal candidate will bring a clinical background, with a nursing degree preferred, combined with hands-on experience in drug safety and the ability to work effectively in a dynamic, development-stage oncology environment. This is an onsite role based in our San Diego office.

Requirements

Bachelor’s degree in Nursing preferred.
Minimum of 6 years of progressively responsible experience in drug safety/pharmacovigilance within the pharmaceutical, biotechnology, or CRO environment, including substantial hands-on clinical-trial safety operations experience.
End-to-end ICSR processing and medical/clinical review, including seriousness, expectedness, causality, MedDRA coding, narrative review, follow-up, quality control, and case closure
SAE management for interventional clinical trials, including clinical database-to-safety database reconciliation and resolution of data discrepancies
Preparation and review of expedited reports and aggregate safety deliverables, including DSURs; experience supporting safety sections of investigator brochures and regulatory submissions is preferred
Direct oversight of pharmacovigilance vendors/CROs, including case quality, timeliness, KPIs, issue management, reconciliations, and inspection-ready documentation
Use of a validated global safety database, preferably Oracle Argus, and familiarity with EDC systems and safety data transfer/reconciliation processes
Development or implementation of pharmacovigilance SOPs, work instructions, safety management plans, and safety data exchange agreements
Ongoing safety surveillance, review of aggregate safety data and listings, signal identification, and communication of clinically meaningful findings to cross-functional stakeholders
Working knowledge of ICH and FDA safety/pharmacovigilance regulations and guidelines; familiarity with global regulatory requirements is a plus.
Knowledge of MedDRA coding and terminology.
Demonstrated proficiency with pharmacovigilance/safety databases, preferably Oracle Argus; experience with EDC systems and safety reporting tools is highly desirable.
Strong clinical judgment and the ability to evaluate complex safety information and communicate its significance clearly.
Excellent written and verbal communication skills, with the ability to collaborate effectively across multidisciplinary teams.
Strong attention to detail, organizational skills, and ability to manage multiple priorities and deliverables in a deadline-driven environment.
Ability to work independently while also contributing effectively within a collaborative, cross-functional team.
At least 2 years of oncology drug-safety or oncology clinical-development experience is strongly preferred, particularly in early-phase clinical trials.
Experience working in a biotechnology or emerging pharmaceutical company environment is a plus.

Nice To Haves

Bachelor’s degree in Nursing preferred.
Experience supporting safety sections of investigator brochures and regulatory submissions is preferred
Familiarity with global regulatory requirements is a plus.
Experience with EDC systems and safety reporting tools is highly desirable.
At least 2 years of oncology drug-safety or oncology clinical-development experience is strongly preferred, particularly in early-phase clinical trials.
Experience working in a biotechnology or emerging pharmaceutical company environment is a plus.

Responsibilities

Support and provide clinical expertise across drug safety and pharmacovigilance activities for oncology clinical development programs.
Manage end-to-end SAE operations, including CRO management for case intake, triage, case review, follow-up, regulatory reporting, clinical database reconciliation, escalation, and closure of safety information.
Oversee case processing activities, including MedDRA coding, narrative development, quality control, medical review workflow, case distribution, and compliance with applicable reporting timelines and procedures.
Contribute to the submission of expedited safety reports, DSURs and other aggregate reports, and related pharmacovigilance deliverables.
Support clinical trial safety activities, including review of aggregate safety data, safety listings, relevant safety analyses, and clinical trial safety documentation.
Collaborate with Clinical Development and Clinical Operations on safety-related aspects of clinical trials, including SAE review, safety data reconciliation, and ongoing benefit-risk assessment.
Contribute to the development and maintenance of safety-related processes, procedures, work instructions, and safety management plans.
Support safety input into clinical study protocols, informed consent documents, investigator materials, and other clinical development documents as appropriate.
Participate in cross-functional safety review meetings and communicate clinically relevant safety findings and recommendations to internal stakeholders.
Provide day-to-day oversight of external pharmacovigilance vendors/CROs, including work allocation, case quality and timeliness, reconciliations, issue escalation, performance metrics, and compliance with safety data exchange agreements and company procedures.
Ensure drug safety activities are conducted in accordance with applicable company procedures, ICH guidelines, FDA regulations, and global pharmacovigilance requirements.
Support inspection readiness and contribute to responses to regulatory inquiries related to drug safety and pharmacovigilance.
Assist with the preparation and review of safety-related documentation for regulatory submissions.
Contribute to continuous improvement of pharmacovigilance processes, systems, and quality practices as the company and its oncology portfolio evolve.