Sr. Director/Executive Director of Drug Safety & Pharmacovigilance Skyhawk Therapeutics seeks a Sr. Director/Executive Director of Pharmacovigilance & Drug Safety to support product safety and compliance.

The successful candidate will report to the SVP of Clinical Development and be responsible for managing drug safety data to support signal detection and risk/benefit profile evaluation, author safety documents, perform QC of safety documents, organize cross-functional Safety Management Team meetings.

Requirements

to ensure compliance with global drug safety regulations while working in a highly collaborative work environment with a multi-disciplinary and diverse team, focusing on multiple programs in parallel.

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 Perform review of Analysis of similar events and Investigator notification for SUSAR reports 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 Review safety data exchange and/or pharmacovigilance agreement with business partners and be accountable for ensuring safety data exchange activities are carried out per SDEA/PVA Perform review of semi-annual SUSAR listings and global risk benefit assessment prepared by CRO Assist in preparation of safety sections & perform review of development safety update report (DSUR) prepared by CROs Perform QC of safety documents as applicable Support signal detection and risk management activities Provide support in periodic review of aggregate safety data for potential trends or signals in a timely manner 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 Review potential issues and safety signals and contribute to the Safety Governance process through the preparation and presentation of safety data 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 Collaborate with CTTs, weekly CRO/sponsor call and monthly medial meeting call with CRO Review and/or contribute to safety sections of key study documents such as Investigator Brochures, protocols, statistical analysis plans, informed consent forms, and CSRs Support preparation of IB RSI table for IB updates in accordance with CTFG Support preparation for DSMB and SMC meetings Author/support in preparation of responses to HA/business partner(s) safety inquiries Par