Life Sciences & Technology
| Clinical Research & Clinical Affairs
A BDN client in Massachusetts is looking for a drug safety manager to act in the capacity of a program lead as a highly-visible member of the drug safety team. On the job, the consultant will act as the primary safety lead on relevant programs, attend various clinical meetings as the safety representative. Additionally, he or she will also be responsible for the oversight and project training of safety specialists.
Oversight over ICSR case processing activities.
Oversight of vendors and business partners.
Oversight and support of reconciliation activities.
Performing continuous quality improvement initiatives to ensure data consistency and a high level of data quality.
Work within cross-functional teams to ensure no issues within post-market and clinical trial activities.
Review clinical trial reports.
Provide input on aggregate reports.
Support safety signaling information to PV Risk Management group.
Train to SOPs.
Author Safety Management Plans for assigned studies.
Compile information for Safety Review Meetings and facilitate (weekly/monthly) meetings with the project team (PV MD, Medical Monitor, clinical project manager.)
Health authority responses - Compiling and supplying as requested, safety information for Regulatory submissions such as IND (Investigational New Drug) safety reports, Annual Safety reports, DSUR/PSUR, or clinical study reports.