Senior Drug Safety Specialist

My client is a midsize biopharmaceutical company

 who is in the midst of an exciting time

as they continue to grow and expand in their clinical area. 

Currently they have a new position they are trying to fill which is a              

        SENIOR Drug Safety Specialist.     

 

                    In this role YOU: WILL process serious adverse event reports from clinical studies.  WILL provide drug information about investigational products to internal and external customers.  WILL perform safety surveillance activities and participate in interactions with business partners and CROs.  WILL assist with the preparation of BLA/NDA and IND reports, investigator communications, product labeling/package inserts, and other reports as necessary.  WILL conduct literature and database searches.  WILL collaborate with internal departments to support and develop standard operating procedures and working practices.  WILL contribute to process development activities within Drug Safety.  WILL provide mentorship to Drug Safety Specialists regarding case management.  WILL have active clinical project team support including protocol review, AE reporting training, and representation at investigator meetings and SAE reconciliation.

The requirements for the position are as follows:  BS in pharmacy or nursing, PharmD, or PA. You MUST have a minimum of 3 to 5 years of drug safety/pharmacovigilance experience, pre-marketing safety preferable.  You should have excellent written and verbal communication skills; ability to write concise descriptive case narratives.  You should also have knowledge of FDA/EMEA regulations regarding adverse event reporting for clinical trials; the EU clinical trial directive.  You should also have project/meeting management experience.  Experience with adverse event software (eg ARISg) and drug information is highly desirable.  Experience working with Immunology/Hepatology products are a plus.

 

Relocation paid if required.