Director, Pharmacovigilance Scientist

Role Overview

• Provide complete Cullinan product life-cycle support for assigned product(s) and participate in clinical study team meetings as appropriate for assigned products
• Represent PV for assigned compounds as a PV lead in cross-functional teams, including Cullinan Safety Management Team (SMT), Safety Review committee (SRC) and other teams with members external to Cullinan.
• Perform ongoing quality review of ICSR representing company review in accordance with study Safety Management Plans, Safety exchange agreements, and SOPs.
• Perform signal detection activities for assigned products in line with approved safety surveillance plan. Perform signal evaluation for any identified signals and author the safety evaluation report. Ensure timely, quality reports/safety analyses related to core deliverables with oversight as appropriate.
• Analyze the safety data, prepare and deliver presentations at SMT meetings.
• Responsible for authoring, preparation and review of safety documents including DSUR, response to health authority or other stakeholder safety queries etc.
• Collaborate with clinical/Medical team to foster communication of potential safety concerns.
• Alert the Head of PV and Medical Safety Physicians to potential safety issues recognized through single case medical review or aggregated data sets.
• Participate and collaborate with the Clinical/Medical team in other risk management/mitigation activities in the clinical studies as appropriate for assigned compounds.
• Responsible for authoring the RSI section of the IB with an ability to provide expectedness of events for regulatory reporting purposes.
• Responsible for authoring the safety section in collaboration with team members on regulatory responses, IBs, review Informed Consent Forms (ICF), CRFs, and providing the necessary quality control for safety assessment.
• Participate and collaborate with Clinical/Medical function in the development of protocols, and ensure safety oversight in cooperation/leadership of the clinical trial medical team
• Ensure timely, quality reports/safety analyses related to core deliverables with oversight as appropriate.
• Serve as a Pharmacovigilance resource to the cross-functional teams.
• Collaborate with clinical/Medical team to foster communication of the potential safety concerns.
• Able to work with and collaborate with Pharmacovigilance Operations (PVO) to manage PV related activities by CRO.
• Participate and collaborate with PVO for SAE reconciliation activities between the clinical and safety databases in accordance with SOPs.
• Participating in and collaborating with PVO in the process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents.
• Review and provide input and support with other departments (e.g., clinical/medical, clinical operations, medical information, regulatory affairs, and data management) groups on PV-related topics for study protocols, statistical analysis plans, and other clinical-related documents.

Requirements

• MS, PhD, or PharmD
• Previous experience as PV/drug safety or clinical research safety (preferably in early clinical development) typically with at least 5 years of experience.
• Experience primarily in immunology and oncology therapeutic areas and any relevant experience or understanding of CART-cell therapy or T Cell engagers would be preferred.
• Ability to utilize safety system database (Argus) for purposes of medical case review and simple queries.
• Knowledge of current and emerging regulatory requirements and expectations including ICH guidelines, EMA GVP Modules, FDA IND and NDA reporting requirements, CIOMS.
• Have led the authoring/preparation of aggregate safety reports (DSURs) for products to meet regulatory requirements.
• Passion, dedication, and a can-do attitude to the career of PVS, able to multi-task.
• Effective written and oral communication skills.
• Demonstrated presentation and collaboration skills.

Benefits

• annual bonus opportunity (25% of salary)
• annual equity awards
• medical, dental, vision, life and disability insurance
• 401(K) plan with employer match
• stock options
• employee stock purchase plan
• flexible non-accrual paid time off
• paid holidays
• end-of-year shut down
• cell phone reimbursement
• tuition reimbursement
• paid parental leave