Sr Drug Safety Associate in San Francisco, CA at Apex Life Sciences

Date Posted: 2/28/2018

Job Snapshot

Job Description

The Senior Drug Safety Associate (Sr DSA) will be responsible for the review, evaluation and management of adverse event reports from studies in accordance with FDA, EMEA, China FDA, other applicable health authorities and ICH guidelines and regulations. The Senior DSA will act as the primary Drug Safety representative for assigned study and will provide support to the medical review team. The Senior DSA will report to Head of Drug Safety Operations.

Specific Duties

  • Assist with oversight and management of safety vendor to ensure timely SAE case entry, processing, notification to business partners, and expedited report submission and tracking.
  • Perform quality check on selected SAE reports.
  • Perform AE/SAE reconciliations.
  • Coordinate and facilitate the review of SAEs by the Drug Safety Medical Reviewers to assure timely assessment of cases.
  • Act as the Drug Safety representative for assigned studies and for safety related activities including participation in the review of study protocols and amendments, safety management plans, study SAE forms and instructions, review of study data management plans, clinical data review plans, data listing reviews, and all other study documents or activities requiring safety review and input.
  • Ensure compliance with local and international reporting of adverse events throughout the program including reporting to Competent Authorities, Ethics Committees, central Institutional Review Boards and Investigators.
  • Facilitate the request for listings of similar events from the drug safety vendor, for the analysis of similar events as needed


  • Minimum of bachelors degree (health care professional preferred, e.g. nurse, pharmacist and etc.), and at least 2 yearsof Drug Safety experience.
  • Ability to read and write Mandarin Chinese required
  • Relevant experience in Drug Safety case processing
  • Experience using a drug safety database (e.g. ARISg or Argus), and generating SAE, CIOMS II, and other standard listings
  • Experience using MedDRA and WHO-DRUG dictionaries
  • Working knowledge of FDA and international pharmacovigilance and clinical safety regulations and guidelines
  • Familiarity with the content of standard pharmacovigilance documents such as SOPs, guidelines, safety plans
  • Experience with exchanging safety data with business partners or affiliates
  • Ability to independently identify problems and effectively offer solutions
  • Excellent written, oral communication, personal organizational skills and resourcefulness
  • Ability to work collaboratively as part of a team in a fast-paced challenging environment
  • Proven proficiency using MS Word, Excel, PowerPoint and Outlook