No more applications are being accepted for this job
- Oversee adverse events handling, including ICSR reviews, assessment of expectedness and relatedness, and collaboration with Regulatory on expedited reports as appropriate for all Dragonfly 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
- 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 DF 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 Dragonfly 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
- 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
- Healthcare professional degree required (PharmD, RPh, NP, RN, BSN, PA, MD)
- 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 early oncology clinical safety is strongly preferred, as is biotech 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