Clinical Safety Associate
1 DNA Way South San Francisco, CA 94080 | Contract
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.
- 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.
- 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.
- Health care professional degree (PharmD, RN, MD)