Hendre Moolman is recruiting for a Senior Drug Safety Specialist to join a company in the pharmaceutical industry in a permanent role in Cambridgeshire.
As Senior Drug Safety Specialist the main purpose of your role would be the overall coordination of serious adverse event (SAE) processes and database activities and the PVG coordination of sponsor and investigator meetings.
Further responsibilities of this Senior Drug Safety Specialist position will include:
- Set up and maintain accurate data within the SAE tracker for all assigned projects
- Set up and QC of data entry into safety database
- Review SAE reports for completeness, clinical consistency and agreement with source documents
- Identify and send SAE queries to investigator sites either directly or through CRAs. Prepare Physician Assessment Form and ensure that medical monitor assessments of SAE documents are completed and distributed according to project requirements
- Coordinate SAE activities for assigned projects, including study start-up, maintenance and close-out activities, SAE reconciliation, budget tracking and forecasting for assigned studies
- Produce and maintain accurate status and metric reports for assigned projects
- Prepare and QC patient SAE narratives
- Produce accurate SAE data for reporting purposes (including regulatory reporting)
- Prepare and submit expedited safety reports and manage the reporting process
- Promptly advise the Manager/Associate Director/Director, Pharmacovigilance of any significant safety and regulatory concerns
- QC safety-related paper documents/electronic data/database entries prepared by others
- SAE reconciliation
- Review Data Management listings, database reports, and validation checks
- Adhere to current global regulations and ICH/local guidelines regarding clinical trials, regulatory documents, and safety issues.
- Perform internal audit activities for departmental processes and procedures
- Assist with external audit activities
- Develop supervisory and mentoring skills for standard SAE processing, study set-up, maintenance, close-out and narrative generation
As Senior Drug Safety Specialist you will have the following qualifications, skills and experience:
- Bachelor's degree in Life Sciences or Nursing
- Proven medical/clinical experience or clinical/safety experience doing SAE processing
As Senior Drug Safety Specialist you will be joining a global pharmaceutical company based in the South East.
How to apply
For more information or to apply for this Senior Drug Safety Specialist position please contact Hendre Moolman on +44 (0)1438 842 970 or email email@example.com.