In search of a physician career change opportunity or a new non-clinical career? An executive search firm is currently looking to fill the following position: Asst Dir, Compliance, Training Drug Safety and Quality. This Position in Connecticut supports the Director in leading the Drug Safety Operations function.
The candidate will manage process documentation and develops and maintain training curricula and materials for the DSP department. They will contribute innovative ideas and implementation plans for further development and continuous improvement of drug safety processes. This position will manage development and implementation of global and local SOPs and WPDs and will follow up with reviewers and approvers to solicit comments and ensure completion of each Procedural Document Management database cycle. They will facilitate and create training presentations, and ensure appropriate training occurs and is documented. They will work with DSP managers to assess skills and identify training need and incorporate into curriculum. S/he will develop training materials in instructor-led and electronic self-study formats and curricula, and collaborate with managers to monitor progress against it. This position will also perform periodic quality evaluations of DSP and assess degree to which continuous improvement mechanisms and mindset are in place. The candidate should be a self-starter, and should possess the following experience/skillsets: Adverse event Case Quality review experience strongly preferred, along with advanced understanding of FDA and international regulations supporting the submission of adverse events for post-marketing and investigational drugs. S/he should also have an advanced understanding of training and procedural documentation requirements in regulated environments and an advanced understanding of continuous improvement principles and related processes.
Minimum 3 years of experience in developing training materials and demonstrated technical abilities to develop e-platform learning; Proficiency with basic MS Office applications; advanced understanding of safety databases and Documentum-based applications.Minimum 8 years of experience in pharmaceutical industry required, including 4 years in drug safety.
If you are interested in this position, please email a cover letter and your CV to info at prnresource.com, and we will provide them to the search firm looking to fill this position.
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