Patient Safety Specialist

SRG; City Of London; Hybrid; GBP 60,000 - 80,000; Part time

Job summary

A global pharmaceutical company is looking for a Patient Safety Specialist to manage pharmacovigilance processes for the UK and Ireland. The role involves collecting and reporting adverse event data, ensuring compliance with regulations, and maintaining safety databases. Candidates should have a relevant degree and at least one year of pharmacovigilance experience. This position offers a hybrid working model, paying up to £35 per hour.

Qualifications

• Prior Pharmacovigilance experience in pharmaceutical industry - at least 1 year experience.
• Knowledge of national and international regulations for pharmacovigilance.
• Knowledge of pharmacological and medical terminology.

Responsibilities

• Managing collection, processing, documentation, reporting of adverse event reports.
• Transcribing and entering data from source documents into safety systems.
• Managing reporting and distribution of safety reports to Local Health Authorities.

Skills

Good communication and interpersonal skills

Analytic and systematic approach

Proactive and independent approach

Competent computer skills

Education

Life sciences, Pharmacy or Medical Sciences degree

Job description

Overview

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

• 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.
• Transcribe, translate, and enter data from source documents into safety systems accurately and consistently with focus quality and on timeliness.
• 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.
• Develop, update, and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
• 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.
• Management and maintenance of all relevant local Patient Safety databases.
• Ensure that relevant local literature articles are screened as appropriate.

Your skills and experience

• Life sciences, Pharmacy or Medical Sciences degree required (post-graduate qualification preferred).
• Prior Pharmacovigilance experience in pharmaceutical industry - at least 1 year experience.
• Knowledge of national and international regulations for pharmacovigilance.
• Knowledge of pharmacological and medical terminology.
• Good communication and interpersonal skills.
• Quality and results oriented.
• Competent computer skills.
• Proactive, independent approach where needed but also comfortable with working in matrix teams at local level.
• Analytic and systematic approach with good problem-solving skills.
• Strong interpersonal skills.

To Apply

If you are interested and want