Director, Safety Scientist

September 26

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Public Relations • Press Release Distribution • Investor Relations • SEC filing • SEO

501 - 1000

Description

• Supports assigned compounds in conjunction with Product Safety Leads (PSLs) • Leads the detection of safety signals and evaluation of safety data • Provides medical safety assessment • Applies effective prioritization and decision making in compliance with regulations • Communicates safety information to internal and external stakeholders • Leads safety data preparation and presentations • Monitors patient safety on clinical trials • Authors safety sections of regulatory submissions

Requirements

• PharmD, NP, RN, or PhD in a medical field or biological science and 8+ years of experience as a Safety (Pharmacovigilance) Scientist. • OR MD (or internationally recognized equivalent) plus accredited residency or have completed a comparable level of post-medical school clinical training relevant to the country of hiring. • 4+ years of clinical experience with patients in a relevant therapeutic area specialty, with significant knowledge of general medicine and 6+ years of pharmaceutical/biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research is preferred. • Prior matrix management team experience • Clinical knowledge of various disease states, drug effects, human physiology and pharmacology • Demonstrated ability to prioritize and manage multiple deliverables simultaneously • Demonstrated leadership, organizational and administrative skills • Prior experience with Regulatory Agency interactions • Pharmaceutical product development experience, including individual study design and filing plans • Experienced in global regulatory requirements for pharmacovigilance

Benefits

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness