AbbVie Associate Medical Director/Medical Director in Lake County, Illinois
The primary job functions for this position are related to pharmacovigilance across the product life cycle for pharmaceutical products and applicable medical devices. Responsibilities will include planning for safety data collection and analyses, human safety surveillance and risk identification/assessment/management. The analysis and interpretation of large amounts of safety data in specific therapeutic areas will be paramount, as will the written and oral communication of the analyses. Ensuring the effective functioning of product safety teams is an important responsibility. * Define, lead and execute the safety strategy within the asset development teams and product safety teams for products for which he/she is the Product Safety Team Lead or supporting. * Contribute to the strategy and authorship of key pharmacovigilance documents including but not limited to new drug application clinical safety summaries, White papers, regulatory responses, periodic safety update reports, safety sections of the investigator brochure, informed consent safety risk language, and the benefit risk plan and assessment. * Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing. * Execute signal detection and evaluation for assigned products in collaboration with Medical analytics. * Risk assessment and management –develop risk management plans and REMS and apply current regulatory guidance for risk minimization, as appropriate * Oversee implementation of the risk management strategy for assigned products. * Understand assigned products’ pharmacology and mechanism of action from a safety perspective, relevant nonclinical toxicology data and clinical AE profile. * Familiarity with individual case safety reports for assigned products and in depth knowledge of the aggregate safety data across clinical trials.
Basic: * MD, DO or equivalent degree is required * A minimum of 2 years of experience relevant to drug safety or clinical research Preferred: * Residency with direct patient management and care of patients is preferred * Board eligible or board certified is preferred * Clinical development or clinical research experience is preferred
Level of position is commensurate upon education and experience of the candidate.
Job Classification: Experienced
Primary Location: USA-Illinois-Lake County
Organization: Research & Development
Travel: Yes, 5 % of the Time
Req ID: 1702733
Equal Opportunity Employer Minorities/Women/Veterans/Disabled