Specialist Nederlandse taal voor NT2

PE Global are currently recruiting for Patient Safety Specialist for a contract role with a leading multinational Pharma client based in London - Hybrid. Manage the collection, processing, documentation, reporting and follow-up of all adverse event reports for all Novartis products from Clinical Trials, Non-interventional Studies, Patient Oriented Program (POPs), Literature, Spontaneous Reports, 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 Country Organization 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.

Prepare and submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to LHA, development and implementation of corrective action(s) as needed.

Develop and update training materials for vigilance and ensure training of Country Organization associates on relevant Patient Safety procedures for AE reporting, including field force and third-party contractors, as applicable

Ensure support to the internal audits, LHA inspections and implementation of the respective CAPA plan.

Medical Doctor, Nurse, Pharmacist), life science degree or equivalent training and experience.

Knowledge of pharmacological and medical terminology

Quality and results oriented.

Computer skills