Drug Safety Scientist
Mary Tilston at CK Clinical is recruiting for a Drug Safety Scientist to join a company in the pharmaceutical industry at their site based in Buckinghamshire on a contract basis.
The main purpose of the role will be to:
- Be responsible for all stages of Adverse Event reporting for both clinical and post-marketed products and coordinate the safety reporting requirements as required for the MAH or Study Sponsor.
- Collect, review and report AEs and pregnancy reports obtained through spontaneous reporting, solicited reports, clinical study, Local Health Authorities and other potential sources, investigate facts and circumstances and report findings to stakeholders and regulatory agencies.
- Assist with the initial quality review and assessment of individual cases and follow up missing information from the AE reporter.
Further responsibilities will include:
- Providing local data as required to support the preparation of Safety Summary reports (PSURs, ASR, etc.) and organize data and narratives regarding adverse events as well as maintaining adverse event files and tracking systems and assisting with the preparation of adverse event reports for submission to regulatory authorities.
- Reviewing regulatory reporting requirements and preparing the preliminary assessment of seriousness, causality and expectedness/listedness.
- Assisting in the implementation of compliance standards and facilitating the collection of compliance metrics as required.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Educated to degree level or above in Biological/Life Sciences or a related field with previous experience of working within Drug Safety and awareness of industry principles of drug development and pharmacology.
- Strong communication and negotiation skills with the ability the communicate with internal and external customers
- Computer literate, ideally with knowledge of database systems.
This is an excellent opportunity to join one of the leading global pharmaceutical companies with great potential and opportunities to develop your career.
For more information or to apply for this position, please contact Mary Tilston on 01438 768717 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL33481 in all correspondence.