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Senior Safety Project Manager

2 months ago

Boston, United States Fusion Pharmaceuticals Full time

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) 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; FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs.


POSITION SUMMARY


The Senior Manager/Associate Director, Global Safety & Pharmacovigilance 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

  • Manage Safety projects/Vendor Oversight.
  1. 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.
  2. Assists in the review of safety data exchange agreements, (SDEA), safety management plans (SMP), and other operational plans with business partners, as required.
  3. Participate in the design of SAE report forms for the capturing of safety data in clinical trials
  4. Performs or oversees reconciliation of AE in collaboration with Data management and all External Fusion business partners as required.
  5. Provide Quality oversight to ensure consistency in the initial evaluation and assessment of adverse event reports and source documentation for completeness, accuracy and legibility.
  6. Ensures timely submission of expedited reports to regulatory colleagues according to US FDA, EU and Canadian regulations.
  7. 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 clinical 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.

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.
  • PV Vendor oversight experience
  • 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.



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.