In search of a physician career change opportunity or a new non-clinical career? An executive search firm is seeking a Director of Drug Safety for a pharmaceutical client in Cambridge, MA.
Incumbent to the position will perform medical review and analysis of serious adverse event reports and act as responsible PV physician and Safety Review Team (SRT) representative for designated development products for clinical trials and programs. You will participate in analysis and preparation of safety data for internal and external use and you will interface with other functional areas (clinical operations, clinical, medical affairs, regulatory, biostatistics and data management) on safety matters. Responsibilities will include: review medical content, coding, expectedness, company seriousness and causality and to provide final follow-up requirements for serious adverse event case reports; review of case narratives for submission documents; in collaboration with Data Management, review and sign off of coding from clinical trials; facilitate and execute reconciliation of clinical and safety databases; perform activities required to serve as PV physician; represent department on study teams (working groups, sub-teams) for assigned products; provide content and review study related documents including protocols, IBs, ICFs, CRFs, SAPs, CSRs ;develop and implement safety process plans for regulatory reporting and safety letter reporting for clinical trials; contribute to preparation and review of periodic reports (IND/Annual Safety); participate in the analysis of safety data from on-going and completed clinical trials; review of product complaints for adverse events; participate in departmental development activities including SOP and Work Instructions initiation and development.
Qualifications include: a medical degree;1-2 years clinical experience following post-graduate training with significant knowledge of general medicine; good level of computer literacy with Microsoft applications; excellent analytical and problem solving skills; excellent oral and written communication skills; 3-5 years clinical research and/or industry experience in Safety or in Clinical Development and knowledge of principles of epidemiology and statistics desired.
If you are interested in this position, please email your CV and a cover letter to info at PRNResource.com, and we will forward it to the executive search firm looking to fill the posiiton.
CG 5351 – 3-04-08
