Sr. Director/Executive Director of Drug Safety & Pharmacovigilance

Skyhawk Therapeutics•Waltham, MA

1d•$300,000 - $445,000

About The Position

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. The successful candidate will oversee the ICSR data quality from safety vendors and ensure compliance with all applicable US and foreign legal and regulatory 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.

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)
Expert knowledge of FDA and EU safety regulations, ICH Guidelines, Good Pharmacovigilance 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
Proficient in Microsoft Suite: Word, Excel, PowerPoint, Outlook
Possesses a sense of urgency and an ability to anticipate and respond quickly to emerging information

Nice To Haves

Experience in rare disease or neurology clinical safety is strongly preferred, as is small molecule biotech experience

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
Participate in the drafting and implementation of pharmacovigilance contracts, agreements, and budget (CRO)
Assist in developing/writing Safety SOPs, Work Instructions and other guidance documents, in compliance with global safety regulations and guidelines
Support audit and inspection readiness of the PV team at all times
Ensure internal regulatory/PV processes and procedures are well documented and support compliant regulatory/PV activities
Assist in preparation of response to regulatory inquiries related to safety
Prepare training materials for internal and external safety presentations as applicable
Perform other department duties as assigned