Senior Medical Director / Medical Director, Pharmacovigilance

• Provide dynamic leadership, strategic direction and governance of patient safety and PV risk management activities
• Lead signal detection and risk management activities for assigned products
• Lead proactive and ongoing analysis and interpretation of non-clinical data, clinical, post-marketing, scientific literature
• Lead PV during interactions with Regulatory Authorities (RA)
• Perform individual case safety report (ICSR) medical review
• Lead multidisciplinary Safety Management Committee (SMC) and Executive Safety Committee (ESC)
• Serve as PV SME in support of regulatory filing activities
• Collaborate with cross functional team
• Address internal/external safety-related requests
• Provide guidance regarding Statistical Analysis Plans
• Author and/or review pre- and post-marketing aggregate safety reports
• Provide PV expertise to support full lifecycle drug development
• Support and/or serve as PV SME during inspection readiness activities
• Develops expertise in gene editing
• Develop training materials and conduct training on PV related content
• Review medical/scientific literature
• Contribute to the development and review of clinical, regulatory, and scientific documents
• Lead/contribute to safety data analyses, messaging and presentations for DMC meetings
• Develop or support development of standard operating procedures (SOPs)
• Contribute to vendor governance activities
• Lead and/or contribute to the development and maintenance of Reference Safety Information (RSI)
• Participates in MedDRA and WHODrug coding and SAE reconciliation activities
• Participate in the development of PV organizational strategy
• Maintain knowledge of new PV/safety regulations
• Maintain knowledge of disease indications for assigned products
• Support hiring, orientation, management, mentorship, and development of PV team
• Support organizational leadership

• MD required, Board certification preferred with 15+ years of experience
• 5+ years of pharmacovigilance experience
• Experience in cell or gene therapy preferred
• Experience as safety lead for asset/approved drug product e.g. Global Safety Lead
• Oversight experience of global medical safety activities
• Demonstrated knowledge of global PV regulatory environment
• Working knowledge of industry standard safety databases (ARGUS and ARISg)
• Knowledge of MedDRA dictionary
• Excellent knowledge of drug development process
• Experience reviewing cumulative safety data
• Experienced in supporting health authority interactions
• Ability to navigate fast-paced and dynamic work environment
• Excellent organizational skills
• Excellent leadership and communication skills

Experience in other serious conditions, including oncology, rare or fatal conditions will be considered