Celgene Associate Director-Medical Reviewer, Global Drug Safety & Risk Management in Summit, New Jersey
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Associate Director-Medical Reviewer, Global Drug Safety & Risk Management
Director, Medical Reviewer, Global Drug Safety & Risk Management
Global Drug Safety & Risk Management
MD or MBBS
Associate Director-Medical Reviewer, Global Drug Safety & Risk Management (GDSRM) is a regional role based at Celgene US, Summit East
Associate Director- Medical reviewer, GDSRM reports at a minimum to Director, Medical Reviewer, Global Drug Safety & Risk Management
Associate Director- Medical Reviewer, GDSRM provides medical advice, assessment and input to the activities of AE case management as well as contributes to global pharmacovigilance & trials activities through ensuring appropriate operational output and support and act as a significant point of contact between Global Drug Safety and Risk Management and Trial Safety Surveillance
Responsibilities include, but are not limited to:
Execute the medical review of individual case safety report (narrative, coding, labeling, independent company causality assessment, pharmacovigilance comment) and manage corrections with assessment as applicable
Ensuring medical accuracy of all aspects of the Case Management group’s output
Ensuring internal escalation and communication of ICSRs to Lead Product Safety Physician for cases of special interest or SUSAR reports from clinical trials and generate discussions with relevant parties (Safety Science, Trials Safety Staff) if required
Developing procedures in support of the Global Safety department having a significant medical context
confirm SUSARs and IND Safety Reports
Manage unblinding of ICSRs from double blinded studies
Create search criteria, generate report and prepare Analysis of Similar Events (AOSE)
Contribute to solving reconciliation coding issues/discrepancies
Review and update generated follow-up letters as appropriate
Review daily line listing of serious cases and manage corrections with Assessment as applicable
Communicate with Lead Product Safety Physician for cases of special interest or SUSAR reports from clinical trials and generate discussions with relevant parties (Safety Science, Trials Safety Staff) if required
Present cases of interest to GDSRM peers during Safety Management Team/therapeutic area meetings.
Manage calls for pregnancy (confirmed or suspected) associated with the use of thalidomide/lenalidomide/pomalidomide.
Contribute to the resolution of issues from cases of high complexity through medical expertise and team interactions
Manage review of cases according to internal timelines
Provide input to aggregate reports including PSURs as required
Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, mandates
Participate in product review meetings.
MD or MBBS required
Two (2) years relevant medical experience minimum, post graduation
Independent decision making and ability to influence required
Excellent written and oral communication skills in English required
Computer proficiency required, including database and MS Office Suite products
Two (2) years pre- and post-marketing drug safety experience preferred
Knowledge of medical aspects in drug safety preferred
Working knowledge of MedDRA, WHO-DD is strongly preferred. Knowledge of clinical data management processes is preferred
Knowledge of global PV regulations preferred
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.