Director of Drug Safety (AdvancedGroup_411714) Berkeley, California

Salary: USD180000 - USD205000 per year

Job Number: 411714

Director of Drug Safety

Primary focus is to manage adverse event reports in relation to products, from both a clinical and post-marketing setting.  This position works with internal Medical Director(s) and other members of Clinical Development and Regulatory Affairs to ensure acquisition of appropriate information, assessment of the adverse events, and timely reporting of serious adverse events (SAEs) including expedited and annual reporting.

 

ESSENTIAL DUTIES:

  • Performs the triage for adverse events to determine regulatory reporting requirements.
  • Reviews published literature of clinical and preclinical reports to provide the context for all reported serious adverse events.
  • Prepares IND safety reports for medical review and for filing by Regulatory Affairs with the FDA and other agencies as appropriate.
  • Participates in reconciliation between clinical trial and safety databases.
  • Communicates and exchanges information with corporate partners regarding safety issues for our client’s products.
  • Coordinates and oversees the notification of investigators and IRBs of IND safety reports.
  • Maintains safety SOPs and assures that the appropriate personnel are trained accordingly.
  • Provides guidance on MedDRA coding.
  • Define and assess requirements for drug safety adverse event database.
  • Will have supervisory responsibilities.

 

MINIMUM QUALIFICATIONS/REQUIREMENTS:

  • BS/BSN required
  • 8-12 years relevant experience within the pharmaceutical industry in managing safety and/or post-marketing surveillance.
  • Understanding of Safety Systems (ARGUS, AERS, etc.)
  • Excellent written and verbal communication skills, organizational skills, and attention to details.
  • Self-motivated, assertive and able to function both independently and as a team member.
  • Computer experience with MS Word, Excel, MS Access, and Email as a minimum.

 

PREFERRED QUALIFICATIONS/REQUIREMENTS:

  • PharmD, RN, MSN or equivalent is preferred.
  • Knowledge of worldwide safety requirements a plus.

Interested candidates please send resume in Word format to dducham@advancedclinical.com Please reference job code 411714 when responding to this ad.