Director, Pharmacovigilance Scientist

Cullinan Therapeutics is a biopharmaceutical company developing potential first- or best-in-class, high-impact therapies for autoimmune diseases and cancer. Cullinan pursues promising therapeutic targets while leveraging core expertise in T cell engagers, which are established in oncology and are now advancing into autoimmune diseases. With a clinical-stage pipeline reputed company on a rigorous scientific approach and purposeful innovation, Cullinan is advancing its mission to deliver new standards of care for patients. The Pharmacovigilance Scientist (PVS) participates in the development and planning of safety strategies for assigned products in early clinical development (Phase I and II clinical studies). This will include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment. PVS will play essential role in developing PV/Safety documents in collaboration with other PV team members and cross-functional teams e.g., medical, clinical operations, biostatistics, and regulatory affairs. Position 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 quality 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 timely, quality reports/safety analyses reputed company to core 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 quality 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 timely, quality reports/safety analyses reputed company to core 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) groups on PV-reputed company topics for study protocols, statistical analysis plans, and other clinical-reputed company documents.

Candidate Requirements

• MS, PhD, or PharmD
• Previous experience as PV/drug safety or clinical research safety (preferably in early clinical development) typically with 8-10 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 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.

Location This position may be remote with occasional travel to the office, or hybrid/based at our corporate offices in Cambridge, MA.

Compensation

The salary reputed company for this role is $210,000 - $270,000. The reputed company provided is based on reputed company reputed company is a reasonable estimate for the reputed company salary pay reputed company for this job at the time of posting. We may ultimately pay more or less than the posted reputed company, and the reputed company may be modified in the future. Actual reputed company salary pay for the role may vary reputed company the reputed company based on several factors including, but not limited to, geographic location, candidate experience, skills, relevant education/qualifications, competencies, external market, internal equity, business needs and/or other job-reputed company factors permitted by law. Additional compensation/benefits include annual bonus opportunity (25% of salary), annual equity awards, medical, dental, reputed company, 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. Cullinan Therapeutics is proud to be an Equal Opportunity Employer. We are committed to creating an inclusive and diverse environment for reputed company and applicants without regard to a person’s race, reputed company, gender, age, religion, national reputed company, reputed company, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Apply tot his job Apply To this Job