Senior Drug Safety Associate

Description

• 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. Including a detailed review of source documentation, assessing cases for reportability, accurate date entry and quality check.
• Preparing clinical narrative summaries independently for AE reports from clinical studies and spontaneous post-marketing reports and formulate follow-up information requests.
• Performing active follow-up via telephone contact with consumers and health care professionals.
• Working with clinical Research Department and Contract Research Organizations, sometimes in a lead capacity, regarding information exchange and safety exchange agreements.
• Coding all AEs in MedDRA independently.
• Ensuring timely reporting ofSAEs/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 ofSAEs 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

• Health care professional degree (PharmD, RN, MD) with at least 2 years drug safety experience AND additional clinical or pharmaceutical experience, or a BS or MS degree with at least 4 years in the area of drug safety or 3 years in drug safety with additional applicable 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.