Sr. Director/Executive Director of Drug Safety & Pharmacovigilance

Responsibilities

• Collaborate, and oversee the work of CROs directly involved in ICSR management, aggregate & periodic reporting, and business partner reporting
• Oversee adverse events handling, including ICSR reviews, assessment of expectedness and relatedness, and collaboration with Regulatory on expedited reports as appropriate for all Skyhawk products
• Provide subject matter expertise in the interpretation of regulations (FDA and ICH guidelines) as related to case processing, SAE case assessments of expectedness
• Perform quality review of completed draft narratives for SAE reports/SUSAR reports received from CROs
• Review/generate appropriate medical/data queries to complete/clarify SAE case information
• Oversee monthly compliance metrics with SUSAR reporting to HAs
• Review of safety management plans
• Provide SME on reconciliation of safety data in safety and clinical database
• Perform review of semi-annual SUSAR listings and global risk benefit assessment prepared by CRO
• Support signal detection and risk management activities
• Perform signal detection activities and analysis to support evaluation and characterization of safety topics for Skyhawk products
• Draft safety topic review (STR) document as needed
• Organize and facilitate cross-functional Safety Management Team (SMT) meetings for signal management, and benefit-risk assessment for Skyhawk products, prepare meeting minutes, and track actions and risk communications
• Review safety concerns escalated from internal and external stakeholders, including competent regulatory authorities, and support strategies for safety assessment in collaboration with the Head of Safety
• Assist in drafting development risk management plan/risk mitigation measures as needed
• Participate in key activities of DS&PV, including safety data review, signal detection, risk communication including safety information updates, and mitigation of potential risks
• Support Development activities as a member of CTT
• Review and/or contribute to safety sections of key study documents such as Investigator Brochures, protocols, statistical analysis plans, informed consent forms, and CSRs
• Aid in the preparation of IB RSI table for IB updates in accordance with CTFG
• Aid in the preparation for DSMB and SMC meetings
• Author/support in preparation of responses to HA/business partner(s) safety inquiries
• Aid in the drafting and implementation of pharmacovigilance contracts, agreements, and budget (CRO)
• Perform other department duties as assigned

Requirements

• Healthcare professional degree required (PharmD, RPh, NP, RN, BSN, PA)
• 10+ years of experience in drug safety/pharmacovigilance in global clinical trial setting (title will be commensurate with the candidate's HCP background and industry experience)
• Experience in rare disease or neurology clinical safety is strongly preferred, as is small molecule biotech experience
• Expert knowledge of FDA and EU safety regulations, ICH Guidelines, Good Pharmacovigance Practice (GVP) and other applicable safety and regulatory guidance documents
• Strong experience with drug safety databases such as Argus, and electronic data capture (EDC) systems, MedDRA and WHO Drug dictionary coding
• Oversight experience of global safety activities, operations, and risk management activities in pre-market setting
• Skilled at overseeing all PV outsourced vendor activities and in a compliance/regulated field
• Adept in managing multiple projects simultaneously in a fast-paced environment
• Team player who applies rational approach to issues and their business implications, with good problem solving and decision-making skills
• Strong interpersonal skills including verbal and written communication, with attention to detail
• Possess a sense of urgency and an ability to anticipate and respond quickly to emerging information
• Possess proficiency in Microsoft Suite: Word, Excel, PowerPoint, Outlook