Contract - Manager, Drug Safety


Manager, Drug Safety,

Seeking a temporary Manager/Sr. Manager Drug Safety (DS) Operations who will contribute to a full range of Drug Safety operational and compliance activities and will be responsible for providing oversight of case processing serious adverse event and other safety related data for clinical trials. The individual must maintain excellent relationships with all stakeholders, vendors, licensed partners and other third parties. Responsibilities are performed under the direction and guidance of the director of drug safety operations and may vary depending on the business needs.

Responsibilities:
  • Responsible for SAE case review
  • Oversight of vendor case processing
  • Responsible for Safety Management Plan maintenance and versioning
  • Responsible for Routine data review and data cleaning activities for ongoing studies
  • Represent drug safety on study teams
  • Review of local ICF versions and changes
  • Help with DS SOP development
  • Help with DSUR preparation

Qualifications:
  • Bachelor's degree in a science or healthcare related discipline or equivalent
  • Minimum 5 years of relevant Drug Safety experience in the biotechnology / pharmaceutical industry
  • Experience operating in global DS regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance (GVP) practices.
  • Strong computer skills (Microsoft Office Suite)
  • Working knowledge of MedDRA and WHO Drug coding dictionaries
  • Demonstrates ownership, initiative and accountability
  • Requires a high level of initiative and independence
  • Extremely effective in a team/matrix environment
  • Flexible to operate comfortably in a rapidly changing environment
  • Must have excellent written and oral communication skills, resourcefulness and personal organization skills
  • Excellent communication and interpersonal skills, including ability to work effectively in team environment, cross-culturally and cross-functionally
  • Excellent verbal and written communication skills with fluency in written and verbal English.
  • Ability to listen and think critically
  • Ability to actively exchange knowledge and ideas
  • Experience with CROs and Business partners strongly preferred


Job Details

Job Type: Contract
Location: Brisbane, CA
Job ID: 20-03903
Date Updated: May 20, 2020