Drug Safety Public Health Coordinator
Proclinical is currently recruiting for a Drug Safety Public Health Coordinator with a pharmaceutical company located in Redwood City, CA.
- Responsible for the accurate and timely book-in and acknowledgment of adverse event information in compliance with applicable SOPs and guidelines.
- Perform simple queries of the safety database, e.g. duplicate searches.
- Maintain and manage dept Safety mailbox, distributing to relevant parties as applicable.
- May perform initial data entry of ICSRs (review, extract, accurately enter AE data from ICSR reports).
- May interpret case-related information including medical conditions, lab results and procedures, as well as compile complete narrative summaries.
- Meet specific data and quality targets for case handling Responsible for regulatory submissions of ICSR and aggregate reports. Assist with tracking and reconciliation of incoming adverse event reports, Investigator letter distribution, and regulatory submissions.
- Coordinate submission of product complaints to the Quality assurance department.
- Participate in department projects, as required and will be cross-trained to handle other functions as deemed necessary
- Recognize situations that require assistance from more senior staff members and seek assistance from appropriate internal and external resources.
- Assist Safety Specialists in sending and tracking follow-up letters.
- Remain current with case handling SOPs, guidance documents and database technology
- Ensure compliance with SDEA and other global regulatory reporting requirements for ICSR
- May assist manager in the preparation of training material and assist in training new employees their functional area.
- May assist manager with writing/reviewing guidelines for their functional area of expertise.
- May assist with other projects as necessary (i.e, study unblinding, reconciliation with vendors, etc)
- Ensure departmental workflow processes and timelines are followed
Skills and Requirements:
- Excellent interpersonal communication skills, both written and oral
- Excellent computer skills in Microsoft environment (Microsoft Excel, Powerpoint and Word).
- Safety database and data entry experience preferred Basic understanding of medical and drug terminology preferred
- Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.