Senior Clinical Drug Safety Scientist
Hendre Moolman is recruiting for a Senior Clinical Drug Safety Scientist Contractor to be based in Buckinghamshire.
The main purpose of your role as Interim Senior Clinical Drug Safety Scientist will be to:
- Lead the coordination and preparation of Development Safety Update Reports (DSURs) and periodic line listings.
- Collect, evaluate, prepare and report adverse events associated with sponsored clinical studies in Europe.
- Ensure complete, accurate, and timely filing of appropriate reports to Regulatory Agencies.
Further responsibilities will include:
- Data-entry of Serious Adverse Event information from source documents with emphasis on time and quality into the global safety database.
- Triage, code of SAE terms, medical history and laboratory data using MedDRA, and code for medications using WHO drug dictionary,
- Perform labelling assessment against reference safety information and preparing medical narratives.
- Data cleaning and SAE reconciliation. Ensure compliance with internal timelines for reporting and processing of case reports from affiliates and from external sources.
- Update global safety database with unblinding information at the end of the study.
- QC check of cases entered into the global safety database by contract research organisations or other relevant parties.
- Coordinate activities for the preparation of DSURs. This will involve a project management role, including a number of activities such as;
- Scheduling kick-off meetings or announcement of DSUR preparation,
- Ensuring individuals draft requested sections of the DSUR per Microsoft Project timelines,
- Track status of DSUR preparation; coordinating the review process of the draft DSUR and approval process for the final draft.
- Support to Primary Author/assigned Physician in addressing reviewer comments and arranging follow-up meetings.
- Review protocols, support trial team in setting up the appropriate SAE reporting procedures internally and at involved CROs.
- Conduct SAE training at investigator meetings.
- Attend study team meetings and complete action items. Escalate significant issues to Senior Management.
- Perform electronic reporting of SUSARs to the European Medicines Agency (EMA) and other relevant EU Competent Authorities within specified timelines.
- Ensure CROs are provided with relevant information to perform paper submissions.
- Prepare periodic line-listings and forward to CROs for submission.
- Perform and support compliance checks in the area of case processing and DSUR submission.
- Attend monthly departmental meetings and prepare agenda and minutes and quarterly scientist team meetings.
- Prepare and maintain local Standard Operation Procedures.
- Meet ICH and local regulatory reporting obligations.
- Maintain up to date knowledge of national and international drug safety regulations.
- Understand and promote the importance of pharmacovigilance in the drug development process and interact with other departments.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Bachelor degree in nursing or pharmacy or other life sciences. A Certificate, Diploma or MSc in Pharmacovigilance is preferred.
- A proven background of safety/clinical experience
- Excellent written and verbal communication skills; good computer skills (Microsoft Office; Word, Excel, Outlook and PowerPoint), good interpersonal skills and the ability to work in a team environment,
- Efficient in time management and multi-tasking, increased knowledge and problem solving skills and increased accountability and ability to work independently.
This is an excellent opportunity to join a dynamic and growing company in an exciting role
- Competitive rate
- Great location
For more information or to apply for this position, please contact Hendre Moolman on 01438 842 970 or 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 CL31494 in all correspondence.