In search of a physician career change opportunity or a new non-clinical career? An executive search firm is looking to fill the positions of Associate Medical Director and Medical Director, Drug Safety, in Stamford, CT.
MD required; graduate training in epidemiology or MPH or equivalent (e.g., MSc) preferred. Minimum of 8 years pharmaceutical industry experience [Drug Safety experience preferred]. The position will be responsible for monitoring the safety profile of Purdue products marketed in the US and in clinical development.
- Perform Medical Review of adverse event reports in compliance with all regulations and guidelines
Write periodic reports in compliance with all regulations and guidelines within specified deadlines for each product;
Perform a review of the scientific literature: identify case reports that meet criteria for entry into the safety database; - Responsible for signal detection surveillance activities including o Review and interpret safety data to detect possible AE signals o Review of case series
Preparing Safety Analyses and Risk Benefit Assessments o Proposing labeling initiatives
Review sections 4.3 + 4.9 of the CCDSs under US responsibility according to schedule
Notify Regulatory of all changes to CCSI and supply related documentation - Own (develop, maintain) SOPs and WPDs related to Medical Drug Safety
Liaise with LOC Directors for day-to-day coordination and issue resolution (PSURs, etc.)
Provide guidance and help to drive understanding and alignment among case handling, aggregate reporting, and signal detection - Reference statements and adverse events included in CCSI and lead related projects as assigned
Ensure compliance with relevant policies and procedures
Review group performance metrics o Identify issues, analyze root causes, define improvement plans - Establish goals in line with department strategies and monitor progress against them
Lead definition and implementation of change initiatives aligned with vision and strategies
Drive resolution of complex, cross-functional issues
Educational Requirements
MD required; graduate training in epidemiology or MPH or equivalent (e.g., MSc) preferred
Years of Experience
Minimum 8 years of experience within pharmaceutical industry
Technical Skills
Knowledge of Drug Safety Database(s), MedDRA, Statistics/Epidemiology, ICH and FDA regulations, MS Office applications
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