Drug Safety Coordinator
Proclinical is currently recruiting for a Drug Safety Coordinator with a pharmaceutical company located in Foster City, CA.
- 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
- 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.
Skills and Requirements:
- Bachelor's degree in science related field with 0-2 years of related experience.
- Pharmacy Technician experience a plus
- Excellent interpersonal and communication skills, both written and oral
- Excellent computer skills in Microsoft environment (Microsoft Excel, Power point and Word).
- Safety database and data entry experience preferred
- Understanding of medical terminology and the ability to summarize medical information is preferred
- The ability to assess data and understand the medical/safety implications.
- Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations is preferred
- A quality driven individual with strong attention to detail and accuracy is required
- Strong organizational skills, and ability to adapt to change
- A demonstrated ability to manage own workload, prioritize, plan and organize assignments and work under strict timelines is required.
- Ability to follow guidelines and procedural documents
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 Claudia Reid at 215-531-5315 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.