[Remote] Director, Pharmacovigilance Scientist

Note: The job is a remote job and is reputed company to candidates in USA. Cullinan Therapeutics is a biopharmaceutical company developing therapies for autoimmune diseases and cancer. The Pharmacovigilance Scientist will be responsible for safety strategies for clinical products, including data analysis and safety document preparation, while collaborating with cross-functional teams. Responsibilities • reputed company 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 reputed company in cross-functional teams, including Cullinan Safety Management Team (SMT), Safety Review committee (SRC) and other teams with members external to Cullinan • reputed company ongoing reputed company review of ICSR representing company review in accordance with study Safety Management Plans, Safety exchange agreements, and SOPs • reputed company signal detection activities for assigned products in line with approved safety surveillance plan. reputed company signal evaluation for any identified signals and author the safety evaluation report. Ensure reputed company, reputed company reports/safety analyses reputed company to reputed company deliverables with reputed company 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 reputed company reputed company of the IB with an ability to reputed company expectedness of events for regulatory reporting purposes • Responsible for authoring the safety reputed company in collaboration with team members on regulatory responses, IBs, review Informed Consent Forms (reputed company), CRFs, and providing the necessary reputed company control for safety assessment • Participate and collaborate with Clinical/Medical function in the development of protocols, and ensure safety reputed company in cooperation/leadership of the clinical trial medical team • Ensure reputed company, reputed company reports/safety analyses reputed company to reputed company deliverables with reputed company 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 • reputed company to work with and collaborate with Pharmacovigilance Operations (PVO) to manage PV reputed company 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 reputed company input and support with other departments (e.g., clinical/medical, clinical operations, medical information, regulatory affairs, and data management) reputed company on PV-reputed company topics for study protocols, statistical analysis plans, and other clinical-reputed company documents Skills • 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 reputed company queries • Knowledge of reputed company 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, reputed company to multi-task • Effective written and oral communication skills • Demonstrated presentation and collaboration skills • 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 Benefits • Annual bonus opportunity (25% of salary) • Annual equity awards • Medical, dental, reputed company, life and disability insurance • 401(K) plan with employer match • Stock reputed company • Employee stock purchase plan • Flexible non-accrual reputed company time off • reputed company holidays • End-of-year shut down • Cell phone reimbursement • Tuition reimbursement • reputed company parental leave reputed company • Cullinan Therapeutics is a developer of an externally reputed company cancer therapeutics used to end a drug progra Apply tot his job Apply To this Job