Sr. Director, Medical Safety & PV | REMOTE | Launch-stage biotech

Senior Director, Medical Safety & PharmacovigilanceMust haves/good to knows:MD with 5+ years drug safety/PV experienceStrong ICSR review backgroundStrong post-marketing experienceThis is a tactical, hands-on, IC role (i.e. no strategy, long-range planning, etc.) No sponsorship or C2C, principals onlyAbout the RoleOur client is advancing treatments aimed at conditions of significant unmet need within autoimmune disease. Anticipating a commercial introduction of an investigational therapy, the organization is expanding its safety and pharmacovigilance function to underpin post-marketing operations. This role will deliver the clinical expertise and supervisory leadership required to maintain rigorous safety monitoring and to ensure the quality of adverse event reporting deliverables.ResponsibilitiesConduct medical assessment of individual case safety reports (ICSRs), including thorough examination of case narratives, company comments, expectedness determinations, and causality judgments across post-marketing safety and pharmacovigilance activities.Contribute medical perspective on serious or complex safety cases, confirming clinical precision and thoroughness.Assist with signal detection and ongoing safety monitoring, including evaluation of aggregate safety datasets and the synthesis and communication of safety findings in forums such as Safety Review Team meetings.Carry out quality control review of safety information and help ensure adherence to international pharmacovigilance obligations.Offer medical guidance on safety matters across functions, supporting clinical development, regulatory affairs, and other internal stakeholders on documents including protocols and Investigator Brochures.Uphold rigorous standards for pharmacovigilance procedures and recordkeeping.Engage directly with principal investigators when further medical clarification or follow-up information is needed.Author safety narratives as needed, including those for serious adverse events occurring in clinical studies.QualificationsMedical DegreeMinimum of 5 years of experience in drug safety or pharmacovigilance, with hands-on medical review of ICSRs.Prior experience operating in a post-marketing environment.Sound clinical reasoning, with demonstrated ability to evaluate causality and clinical significance of adverse events.Track record of working with investigators and partnering across functions.Comprehensive knowledge of international pharmacovigilance regulations and safety reporting expectations spanning both clinical trial and post-marketing settings.