Product Safety Monitor

A recognized leader in the biotechnology industry, we use the latest advances in science, technology and medicine to develop innovative products that improve the quality of human health. 

 

Management of data for adverse event information received by MedImmune.  Utilize medical knowledge to prepare individual case safety reports and periodic reports, obtain follow-up information, and prepare standard and ad hoc reports. Responsible for safety surveillance and assisting in the evaluation of potential safety signals in clinical trial and spontaneous reports in collaboration with Medical Director/Operational Managers. May mentor other Product Safety interns and serve as cross-functional team member as needed.  Participate on team projects to accomplish team and department goals and objectives.

Some specific responsibilities of the position are as follows:Reviewing, triaging and processing initial and follow-up adverse event reports for clinical studies and marketed products. Ensuring compliance with worldwide regulatory requirements for safety surveillance. Reporting for post-marketing AEs and liaising with Regulatory regarding SAEs. Assisting in the development of risk management plans and safety reporting criteria for protocols.  Evaluating individual SAE reports and aggregate safety data (e.g., search for signals/trends). Assisting in preparation of BLA/NDA and IND safety reports and PSURs, investigator communications, product labeling/package inserts, and other documents as necessary.Active participation in departmental projects, validation exercises, and FDA inspections.

May provide guidance and training to personnel. Bachelor?s and/or advanced degree in a related discipline is preferred. Health professional degree such as RN, BSN, MSN, PA, NP, RPh, PharmD, or other relevant health professional degree required. Requires 1 to 3 years of clinical/post-marketing safety or related experience.Familiarity with clinical trials conduct, experience in medical writing, strong communication skills, and the ability to collaborate and interact with a wide range of health professionals and company personnel.  Thorough knowledge and understanding of FDA and EMEA regulations, ICH guidelines, guidelines pertaining to drug safety, cGMPs and cGCPs.

Experience with adverse event software (e.g., ARISg,) and coding dictionaries (e.g., MedDRA) is desirable.

 

Please send resume, including job code, to: MedImmune, Inc., HR Department, Job Code: 4213-001, One MedImmune Way, Gaithersburg, MD 20878; Fax: 301-398-4215; E-mail: JobOpenings@medimmune.com EOE, M/F/D/V