Fusion Pharmaceuticals (NASDAQ: FUSN)
is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion's clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial. In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. The Company recently received IND clearance for FPI-2068, the first novel TAT under the collaboration, which targets EGFR-cMET. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. To support Fusion's growing pipeline of TATs, the company has signed strategic actinium supply agreements with TRIUMF, Niowave, and BWXT Medical.
The Safety Project Manager will oversee specific aspects of safety operations including adverse event processing, reporting, and reconciliation for assigned investigational Fusion products. This individual may serve as a liaison to external contract safety providers and company personnel for safety issues, working in close collaboration with colleagues from Clinical Operations, Regulatory Affairs, Quality and Medical Affairs. The position will report to the Senior Director, Global Safety and Pharmacovigilance.
RESPSONSIBILITIES
Proactively oversees creation and continuous improvement of adverse event reporting and management processes on a global scale, including the oversight of the case management and regulatory submissions activities.
Assists in the review of safety data exchange agreements, (SDEA), safety management plans (SMP), and other operational plans with business partners, as required.
Participate in the design of SAE report forms for the capturing of safety data in clinical trials
Performs or oversees reconciliation of AE in collaboration with Data management and all External Fusion business partners as required.
Provide Quality oversight to ensure consistency in the initial evaluation and assessment of adverse event reports and source documentation for completeness, accuracy and legibility.
Ensures timely submission of expedited reports to regulatory colleagues according to US FDA, EU and Canadian regulations.
Support signal management activities, including Signal investigations
Oversees safety vendor for all safety and PV operational activities and provides oversight of the ARGUS Global Safety Database implementation and updates through the safety vendor.
Act as the primary contact point for safety project-related matters on assigned clincial studies
Contribute to safety requests from Regulatory authorities
In collaboration with Regulatory Affairs, provide information to be submitted to Regulatory Authorities and ensure timely submission of expedited safety reports.
Other Responsibilities
Interacts on a regular basis with Fusion safety colleagues to identify process improvement strategies and provide safety input for all operational aspects of drug safety and pharmacovigilance
Develops, maintains and ensures documentation of drug safety and pharmacovigilance processes and procedures.
Provide operational input into PV SOPs
Maintain aggregate report schedule, ensures proper SOPs are in place and current to support aggregate report production.
Collaborate on documents such as Investigator brochure, clinical study protocols, ICF, DSUR, CSR, or other clinical trial progress reports.
As required, participate in strategic planning, workflow development, standard operating procedure updates, development & compliance, audits, data analysis and clinical team meetings.
Provide support to Quality team and support product complaint activities as needed.
Ensure compliance with FDA regulations and ICH guidelines to meet all regulatory drug safety and pharmacovigilance reporting requirements.
Escalate issues to management as needed
Other duties as assigned.
REQUIREMENTS
Bachelor's degree in Science (preferred in pharmacy, nursing or life sciences), Masters degree preferred but not required
Minimum 5-7 years of pharmaceutical experience with a demonstrated focus in PV operations and compliance in the clinical and post-marketing setting
Radio pharmaceutical experience preferred but not necessary
Experience with clinical data capture systems and electronic SAE forms
Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA.
Working knowledge and experience with European and Canada pharmacovigilance regulations preferred.
Thorough understanding of Individual Case Safety Reports (ICSR) processing operations required, including working with outsourced service providers and Contract Research Organizations as well as all steps through case receipt, case processing, medical review and regulatory submission
Thorough knowledge of relevant FDA and International Conference on Harmonisation (ICH) guidelines required, including Good Clinical Practices (GCP) guidelines.
Demonstrated technical, administrative, and project management capabilities.
Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills.
General understanding of the drug development process
Excellent attention to detail and accuracy
Adaptable to changing priorities.
Proficient computer skills, including Microsoft Word, PowerPoint and Excel.
Fusion requires all employees to be current with their COVID vaccination requirements.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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