Description
DUTIES- 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 post-marketing reports and formulating follow-up information requests.
- Performing active follow-up via telephone contact with consumers and health care professionals.
- Work with Medical Reviewer on final pharmacovigilance commentary and case closure.
- 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 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.
SKILLS
- 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) 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.