The role of the Global Drug Safety Fertility/Immunology Product Leader is to ensure effective proactive safety strategies for the assigned product(s) be it a development compound or a marketed product; delivery of safety aspects input to clinical development; and risk management and benefit-risk evaluation for the product. This includes delivery of the medical evaluation of single cases; signal detection and evaluation activities; all periodic safety reports, risk management plans and regulatory documents; ensuring definition, implementation and evaluation of risk mitigation actions, and safety input to clinical trial activities as appropriate.
EDUCATION • MD (University degree) with broad clinical experience with profound (at least 7 years) work experience in pharmacovigilance area • Fluent in written and spoken English • Formal coursework in epidemiology, biostatistics or equivalent analytic training preferred but not required WORK EXPERIENCE Necessary professional experience • 10 years of industry experience, preferably including both clinical development and pharmacovigilance experience (including medical safety evaluation and safety based decision making) preferred • Excellent knowledge of product development process and experience of cross-functional team work. • Preferentially prior experience with NDA/BLA or equivalent regulatory submissions or working experience from a Regulatory Agency on reviewing submission files • First hand experience in handling safety issues related to known target organ toxicities (e.g. hepatic, renal, hematological) and good understanding of the therapeutic area • Professional experience in an international environment • Several years of industry experience (minimum 5 years)
Call Lisa Bourbeau at 919-838-7478 or Email at firstname.lastname@example.org