Position Summary Serve as a subject matter expert and thought leader for drug safety activities across the portfolio, applying oncology drug development, precision medicine biomarkers, and global regulatory frameworks. Responsibilities Perform comprehensive medical review of ICSSs (clinical trials and post-marketing): assess significance, seriousness, expectedness, and causality; provide medical causality assessments for SAEs/SUSARs; review medical narratives and ensure documentation accuracy. Analyze similar cases and conduct case series evaluations to support signal detection and regulatory decision-making. Provide medical guidance to case processing teams and ensure compliance with global pharmacovigilance regulations. Review aggregate safety data in standardized regulatory reports (e.g., Investigator Brochures, DSURs, PBRERs, PSURs) to support balanced medical presentation and signal detection. Ensure appropriate MedDRA and WHO-DD coding with CRO/DSPV teams. Coordinate submission of expedited and periodic safety reports to regulators and required distribution to partners. Oversee set-up of new safety projects, including study-specific Safety Management Plans and safety systems/processes. Lead safety data analysis and signal management; conduct advanced signal detection integrating preclinical, clinical, and literature data. Author/review complex safety documents (e.g., IND Annual Reports, PADERs, DSURs, PSURs, integrated safety summaries) and safety sections of clinical/regulatory submissions. Lead department operations (procedures, training, service provider oversight, audit preparation) and develop departmental policies across jurisdictions. Lead cross-functional liaison and represent Drug Safety in clinical team meetings. Solve complex safety problems and drive innovative monitoring approaches for novel modalities (e.g., ADCs). Qualifications / Skills MD or equivalent advanced degree required. 8–12+ years progressive drug safety/pharmacovigilance experience in biopharma. 3–4+ years in leadership roles managing safety teams. Oncology drug development and precision medicine expertise; experience with targeted/bio marker‑driven development and novel modalities. Deep knowledge of global pharmacovigilance regulations (ICH, FDA, EMA, GVP) and precision medicine guidance. Advanced expertise in safety signal detection and benefit‑risk assessment; ability to integrate biomarker data into safety monitoring. Strong written/verbal communication; ability to influence stakeholders. Experience interfacing with regulatory authorities; biotech/pharma experience with marketed products. Benefits Eligible for annual bonus and equity incentive awards (not commission‑based). Comprehensive benefits: medical/dental/vision, life/disability, flexible spending, 401(k), paid time off, paid holidays, and other benefits. #J-18808-Ljbffr Scorpion Therapeutics
Sterile Processing Tech Location: Clyde, NC Agency: SkyBridge Healthcare Pay: Competitive weekly pay (inquire for details) Contract Duration: 13 Weeks Start Date: ASAP About the Position Please contact a recruiter for details.
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