Patient Safety Specialist
Location - London/Remote (hybrid working)
Duration - 9 months initial (Temporary)
Rate - up to £35 per hour (Umbrella)
At SRG we are partnered with a global pharmaceutical company who are searching for an experienced Pharmacovigilance professional to join the team as a Patient Safety Specialist. The successful candidate will operate in this capacity for UK and Ireland, supporting management of Patient Safety operational processes and ensuring compliance with relevant pharmacovigilance (PV) regulatory requirements.
The Role Responsibilities include:
1. Managing the collection, processing, documentation, reporting and follow-up of all adverse event reports for all company products from Clinical Trials, Non-interventional Studies et al and any other source of information.
2. Transcribe, translate, and enter data from source documents into safety systems accurately and consistently with focus quality and on timeliness.
3. Manage reporting/submission/distribution of safety reports/updates/information (e.g., SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities (LHA) and/or clinical operations in cooperation with other Departments.
4. Develop, update, and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements
5. Perform reconciliation with other departments (e.g., Medical Information, Quality Assurance, and Third-party contractors, as applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources.
6. Management and maintenance of all relevant local Patient Safety databases
7. Ensure that relevant local literature articles are screened as appropriate.
Your skills and experience
8. Life sciences, Pharmacy or Medical Sciences degree required (post-graduate qualification preferred)
9. Prior Pharmacovigilance experience in pharmaceutical industry - at least 1 years' experience
10. Knowledge of national and international regulations for pharmacovigilance
11. Knowledge of pharmacological and medical terminology
12. Good communication and interpersonal skills
13. Quality and results oriented.
14. Competent computer skills
15. Proactive, independent approach where needed but also comfortable with working in matrix teams at local level
16. Analytic and systematic approach with good problem-solving skills
17. Strong interpersonal skills
To Apply
If you are interested and want to find out more about this role, please click to apply or contact Theo Charles to discuss further.