Clinical Safety Associate

South San Francisco, CA 94080 | Contract

Post Date: 07/03/2018 Job ID: 4455 Industry: Drug Development - Med/Clinical Affairs

Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.

 

Duties:
  • The Senior Drug Safety Associate (DSA) is responsible for: Establishing work priorities and direction independently with minimal input from Manager.
  • Collecting, documenting, and processing adverse event (AE) reports from clinical trials and post-marketing sources in accordance with company Standard Operating Procedures (SOPs) and work practices to ensure and maintain regulatory compliance. 
  • This includes detailed review of source documentation, assessing cases for reportability, accurate data entry, and quality check.
  • Preparing clinical narrative summaries independently for AE reports from clinical studies and spontaneous post-marketing reports and formulates follow-up information requests.
  • Performing active follow-up via telephone contact with consumers and health care professionals.
  • Coding all AEs in MedDRA independently.
  • Ensuring timely reporting of SAEs/AEs to Regulatory Authorities, and cross-reporting to pharmaceutical partner(s).
  • Participating in the preparation of aggregate safety reports, such as biannual safety reports to Ethics Committees and annual reports to regulatory authorities.
  • Conducting periodic reconciliation of SAEs between drug safety and clinical trial databases for ongoing clinical studies with little or no supervision
  • Representing the DSRM department on project teams. 
  • Completing individual projects in support of DSRM department initiatives
  • Working with Clinical Research Department and Contract Research Organizations, sometimes in a lead capacity, regarding information exchange and safety exchange agreements.

 

 

Skills:

  • Health care professional degree (PharmD, RN, MD) with at least 2 years drug safety experience AND additional clinical or pharmaceutical experience.
  • Strong verbal and written communication skills demonstrated by the ability to interpret and communicate medical information and write summary reports, if needed.
  • Strong interpersonal skills especially for proactive drug safety representation on clinical/project team and investigator meetings, and communications with contract research organizations (CROs) involved in safety reporting.
  • Candidate must have the ability to organize workflow activities, able to multi-task, be performance-driven, and possess good decision-making skills.
  • Computer literacy including working knowledge of computer applications such as word processing, spreadsheets and electronic mail is required; experience with data entry into drug safety databases strongly desired; ARISg experience a plus.
  • Knowledge of domestic and international drug safety regulations, industry practices and standards as well as clinical knowledge in appropriate therapeutic area is preferred.

 

Education:

  • Health care professional degree (PharmD, RN, MD)
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