An executive search firm is looking to fill the position of Assistant Director Premarketing Safety Assessment in Connecticut.
Incumbent to this role will operationalize and/or execute work required to create and maintain a benefit-risk assessment for each product in clinical development. Responsibilities include: prepare materials to be utilized in identification of critical safety issues and contribute to the creation and implementation of actions plans to address those issues; provide real-time individual case medical review of events deemed medically important in parallel with review of cumulative and aggregate study data; provide assessment and contribute to improvement of these review processes; review output of clinical/drug safety database reconciliation process, coding reports, and independent literature reports to confirm appropriate identification and categorization of important medical events within clinical and safety databases; identify and evaluate potential safety signals for assigned developmental compounds; collaborate with internal and external personnel contributing to assessment of safety signals and/or benefit-risk assessments; and provide drafts of safety sections of documents intended for regulatory submissions or internal use and/or review safety materials completed by external/internal personnel. Qualifications include: an MS, MPH, PharmD degree or equivalent; a minimum of 5 years of experience in a pharmaceutical clinical development team, including experience in narrative development, review of aggregate safety data, completion of clinical study reports, and preparation of regulatory agencies on safety-related topics; excellent team leadership skills; problem solving skills, logical approach based on sound clinical judgment; the ability to operate effectively in a global matrix environment; and awareness of current regulatory environment as it applies to emphasis on assessment of safety data including aggregate data analysis.
If you are interested in this position, please email a cover letter and CV/resume to info at prnresource.com, and we will forward your information to the search firm looking to fill the position.
CG 11-09
