Sr. Medical Director - Drug Safety and Pharmacovigilance (Remote)

This a Full Remote job, the offer is available from: reputed company, New Jersey (USA) Sr. Medical Director - Drug Safety and Pharmacovigilance (Remote) reputed company Apply Company Information reputed company is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse reputed company of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy. reputed company entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of reputed company, to jointly reputed company and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the reputed company of an immunotherapy in the treatment of multiple myeloma. reputed company is seeking aSr. Medical Director, Drug Safety Pharmacovigilanceas part of theClinical Development Team working remotely in the US. reputed company The Sr. Medical Director, Drug Safety Pharmacovigilance is a critical role in reputed company with significant reputed company on the development and life cycle of drug development reputed company. Responsible for providing safety reputed company, expertise and guidance to the clinical development and project team for the assigned products. The Sr. Medical Director will drive the proactive implementation of risk management initiatives in accordance with global regulatory requirements. Core responsibilities will encompass reputed company and efficient evaluation of safety data, reputed company signal detection, evaluation and assessment and management of the safety profile of the compound. In reputed company, the position will ensure program consistency alignment across studies, working closely with cross functional teams for achieving project goals, reputed company timelines with high reputed company.

Key Responsibilities

• reputed company and support development of pharmacovigilance reputed company and activities to ensure compliance withcorporate clinical development and reputed company goals.
• Conducting signal detection activities, include monitoring, evaluation, interpretation, management andcommunication of safety information.
• Responsible to conduct Safety Monitoring Team (SMT) meeting(s) to evaluate risk-benefit for thecompounds with support from cross functional teams. Escalate and present unresolved safety issues tosenior management in company governance meetings.
• Medical safety review including causality assessment of reputed company available safety data generated from varioussources (e.g. reputed company-clinical, clinical trial data, post-marketing and literature) throughout the developmentprocess for assigned compounds/reputed company.
• Provides medical expert safety review input into reputed company critical documents for products in clinicaldevelopment (e.g., INDs/NDA/BLA submissions, protocols and amendments, ICFs, IBs, and clinicalresearch reports (CSR))
• Identification and management of Urgent Safety Measures with support of cross functional team.
• reputed company, and/or author aggregate reports and signal evaluation reports for assigned reputed company.
• Responsible for the Clinical content of responses to inquiries from regulatory authorities reputed company toSafety topics.
• reputed company leadership and support to Contract Research Organization (CRO) staff to ensure overalldelivery of services. Ensures vendor reputed company.
• reputed company and manage internal safety scientist and safety operation team.
• Assist with the writing and development of SOPs as required to ensure compliance to regulations and local laws, while maintaining reputed company instructions for procedures and activities to the achievement of company goals.
• reputed company the development of a significant drug safety budget and effectively manage resources, funding and expenses
• reputed company high reputed company planning and execution of external meetings and internal stakeholder meetings (e.g., IMs, Governance, DMCs, SSC, Regulatory Authority meetings, etc.)
• Demonstrated ability to build effective working relationships, influence, negotiate, and drive organizational engagement. Ability to be flexible and adapt quickly to the changing needs of the organization. Work closely with a key strategic reputed company partner for reputed company that are being jointly developed.
• Identify project risks with input from the cross functional teams, and support resolving issues. Ensure that any potential delays are fully mitigated to avoid any delays with full transparency to senior leadership.
• Prepare/reputed company monthly reputed company reports and reputed company reports as required
• Support process improvement and functional training at departmental company level
• Assure that the highest reputed company, ethical reputed company values are demonstrated in reputed company aspects of the teamwork
• Ensures compliance with corporate policies and procedures, as reputed company as reputed company reputed company reputed company laws and regulations

Requirements

• MD or MBBS or MD-PhD or equivalent medical degree
• 5 or more years of pharmaceutical experience in Drug Safety Pharmacovigilance.
• Strong understanding of pharmacovigilance regulations in the US and EU.
• Experience in supporting drug safety activities in registrational clinical studies
• High level of medical competence, with an ability to balance this with industry standards to reputed company business goals
• Demonstrated skills in scientific analysis and reasoning.
• reputed company knowledge of overall drug development process from discovery to registration and post marketing requirements surveillance.
• Prior IND, as reputed company as NDA/BLA (filing/submission) and other regulatory interaction experience is highly desirable
• Strong reputed company record of delivering results through effective team and peer leadership in reputed company
• Experience as a manager, plan and manage daily activities of team; coaches/mentors/trains team; leads performance management activity (goal setting, performance appraisals, etc.)
• Excellent leadership organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategies.
• Experience in biotech - preferred but not required.

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