Job Listing: Sr. Associate Director of Medical Safety

Our client, one of the largest and fastest growing pharmaceutical companies in the world, is looking for an Sr. Associate Director of Medical Safety to join their team.

On a DAILY BASIS, the Sr. Associate Director of Medical Safety will be responsible for the following:

- Responsible for assessing individual case reports to determine regulatory reporting responsibilities; assessing benefit-risk; assessing potential drug-related toxicities; assessing potential safety signals; writing individual case assessments and interpreting aggregate safety data; determining potential impact of safety data on product labeling or development status of investigational compounds.

- Responsible for preparation and management of medical safety documents, e.g. PV plans and risk assessment documents, submitted to FDA; responses to FDA inquiries regarding product safety; and assists with FDA inspections within Drug Safety.

- Assist with developing custom reports to assess safety data from ARISg

- Reviews protocols, aggregate global and local submissions to ensure procedural compliance and to assess medical content for accuracy.

- Responsible for communicating potential safety issues, activities and accomplishments to the Executive Director of DSI as well as colleagues in Corporate Drug Safety and Regional Center Europe as appropriate.

- Responsible for writing international case assessments for cases processed within the Regional Center. Responsible for working with colleagues in Corporate Drug Safety and Regional Center Europe to assess potential safety signals and recommend updates to the company core data sheet and local product labeling.

- Responsible for writing NDA periodic reports as part of aggregate data review.


TO BE QUALIFIED for the Sr. Associate Director of Medical Safety, individuals MUST have a Medical Degree (MD or international equivalent) with board certification and license to practice medicine with advanced training in epidemiology, applied statistics and/or data management desirable. Strong leadership skills acquired through a minimum of three to four years prior clinical experience (excluding internship and residency) or two to three years of safety related pharmaceutical industry experience. Understanding of all phases of drug development (I-IV) and federal regulations pertaining to IND and NDA regulations. Advanced degree in public health, e.g MPH, PHD, desirable.

All qualified candidates should contact Crysta Lemon at 203-317-2522 or via e-mail at clemon@aerotek.com

Required Skills for Sr. Associate Director of Medical Safety Job:

About Aerotek Scientific:

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.