SUMMARY: Under the direction of the Vice President, Global Drug Safety, The Manager, Drug Safety is considered part of the Drug Safety department’s leadership team and leads the Americas safety hub\ manages the activies and staff of the US Drug safety hub, assuring harmonziation with the other safety hubs under the direction of the VP DS
Tasks may include but are not limited to:
Management and Development of US Hub Staff, including DSAs, Sr. DSAs, , located therein.
Act as an operational guidance resource for all ongoing (and potential) studies
When assigned, liaise with sponsors on global/general safety issues
Ensure applicable documentation and processing of serious adverse event and Serious Adverse Drug Reactions occurs as per agreed contractually and that all processing activities are conducted in accordance with all US regulations
Participate in the development of procedures (SOPs, WP,s, etc) to structure the above activities
Review US DS hub department status reports, keep DS management apprised of any potential/actual study or staffing issues, and assist with developing solutions
Ensure appropriate resolution of US DS Hub departmental personnel issues
Assist with assignment staff to newly awarded projects
Assits in the interdepartmental liaison between Safety staff and other WCT departments as well asexternal vendors for project related issues
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
Safety background (nursing, pharmacy, or medicine) with relevant clinical experience
8 years drug safety or Pharmacovigilance experience
Excellent computer skills (Word, Excel, Access)
Excellent organizational and time management skills
Excellent communication skills
Excellent presentation skills
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.
Worldwide Clinical Trials - 12 months ago