Associate Director, Drug Safety

As the Associate Director, Drug Safety for Jazz Pharmaceuticals, you will build and manage a team of safety associates and safety scientists for a variety of investigational agents and commercial products. You will manage individuals who represent the Drug Safety Department on clinical project teams and have responsibility of processing clinical and post marketing adverse events. In addition to this management role you will participate in cross functional clinical project teams providing consultation regarding safety issues relevant to the program as well as contributing to the development of study related documents and ensuring that processes are in place for international reporting of adverse events.

The Associate Director, Drug Safety will: Contribute to the medical monitoring of clinical programs as well as monitoring the risk benefit profile of marketed drugs ensuring that the safety profile is adequately represented in prescribing information and informed consent forms. Perform individual and aggregate medical reviews, interpret the clinical significance of incoming adverse events reports, and prepare individual or aggregate safety reports and assist in signal detection, evaluation, and communication of safety trends. Be responsible for triage of adverse event reports as well as for ensuring that the individuals in the group are adequately trained and perform according to company standards. Be responsible for ensuring that PSURs, Periodic Reports and all regulatory reports are prepared according to company standards and finalized for timely submission. Serve as a primary resource of safety information, providing in-depth knowledge of products in assigned therapeutic areas. Manage the performance of periodic reviews of safety labeling for drug products, particularly with regard to product safety update reports Ensure SOPs and work instructions are strictly followed Enhance SOPs and Work Instructions as needed Address the operational questions from clinical sites, CROs, and other departments in the company. Ensure the Drug Safety staff is updated on most current regulations relevant to a Drug Safety organization (new ICH steps, new FDA or international guidelines, etc). Supervise the quality of the queries to health care professionals or consumers. Collaborate with other Jazz Pharmaceuticals departments (Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Project Management) as appropriate. Work closely with all involved parties (legal, facilities, finance, etc…) to finalize contracts with individual consultants. Manage the training and development of Drug Safety personnel Mentor Drug Safety Associates and Scientists and Drug Safety Coordinators to achieve high-quality safety data collection and processing, including providing regular performance feedback, development and coaching to direct reports and contract employees

Essential Requirements: RN or PharmD with a minimum of five years of Drug Safety experience within the Biotech/Pharmaceutical industry.

MD with Drug Safety experience preferred.

Equivalent combination of education and managerial experience.

Extensive experience in drug safety and/or pharmaceutical industry related positions

Thorough knowledge of drug safety regulations and guidelines in the US and EU.

Experience with MedDRA, safety database management, and computerized data analysis required.

Other requirements include: strong management skills, including experience leading a team; strong oral and written communication skills; ability to work in a collaborative environment including outside vendors and corporate partners.