Interim Senior CSPV
Mary Tilston at CK Clinical is recruiting for an interim Senior Clinical Safety Scientist to join a company in the pharmaceutical industry at their site based in Buckinghamshire on a contract basis.
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 including scheduling kick-off meetings or announcement of DSUR preparation, ensuring individuals draft requested sections of the DSUR per Microsoft Project timelines and track status of DSUR preparation; coordinating the review process of the draft DSUR and approval.
- Lead and manage projects for sponsored clinical trials including reviewing protocols, supporting trial team in setting up the appropriate SAE reporting procedures internally and at involved CROs as well as conducting SAE training at investigator meetings.
- Ensure complete, accurate, and timely filing of appropriate reports to Regulatory Agencies.
Further responsibilities will include:
- Collecting, evaluating, preparing and reporting adverse events associated with sponsored clinical studies in Europe.
- 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.
- Electronic reporting of SUSARs to the EMA and other relevant EU competent authorities within specified timelines.
- Performing labelling assessment against reference safety information and preparing medical narratives.
- Data cleaning and SAE reconciliation. Ensuring compliance with internal timelines for reporting and processing of case reports from affiliates and from external sources.
- Updating global safety databases 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.
- Supporting Primary Author/assigned Physician in addressing reviewer comments and arranging follow-up meetings.
- Attending study team meetings and completing action items. Escalating significant issues to Senior Management.
- Performing electronic reporting of SUSARs to the European Medicines Agency (EMA) and other relevant EU Competent Authorities within specified timelines.
- Ensuring CROs are provided with relevant information to perform paper submissions.
- Preparing periodic line-listings and forwarding to CROs for submission.
- Performing and supporting compliance checks in the area of case processing and DSUR submission.
- Attending monthly departmental meetings and preparing agenda and minutes and quarterly scientist team meetings.
- Preparing and maintaining local Standard Operation Procedures.
- Meeting ICH and local regulatory reporting obligations.
- Maintaining up to date knowledge of national and international drug safety regulations.
- Understanding and promoting 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 Mary Tilston on 01438 768717 or firstname.lastname@example.org. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer who 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 CL33722 in all correspondence.