Senior Director, Medical Safety & Pharmacovigilance

Senior Director, Medical Safety & Pharmacovigilance

About the Role

Our 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.

Responsibilities

• Conduct 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.

Qualifications

• MD or comparable medical degree required.
• Minimum of 5 years of experience in drug safety or pharmacovigilance, with hands-on medical review of ICSRs.
• 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.

Preferred Qualifications

• Prior experience operating in a post-marketing environment.