​Pharmacovigilance Specialist - Medical Devices

Location Europe
Discipline: Medical & Pharmacovigilance
Job type: Permanent
Salary: £Salary: On application
Contact name: Louise Clark

Contact email: louise.clark@rbwconsulting.com
Contact phone: 01293584300
Job ref: 21544
Published: 25 days ago
Expiry date: 23 May 2021

​Location: UK, Italy and Spain (Remote working)

Data driven and quality focused our client an established European CRO, is looking for PV Specialists to join their growing PV team.

This is a great opportunity to take the next step in your PV career. Educated to degree level with a minimum of 12 months PV/Drug safety experience you will be responsible for the Safety Management Plan (SMP) drafting, handling of SAEs, SUSARs and DSUR as well as carrying out pharmacovigilance activities related to: Pre-marketing Pharmacovigilance, Post-Marketing Vigilance, Phytovigilance and Medical Device vigilance.

Typical responsibilities will involve

Pre-marketing pharmacovigilance

  • Safety Management Plan (SMP) drafting;

  • Handling of SAEs and SUSARs, .CIOMS-I form drafting and submission to Competent Authorities and Ethics Committee;

  • Handling of USM (Urgent Safety Measures);

  • Preparing and distributing SUSARs Line Listing and Handling and distributing DSURs (Development Update Safety Reports);

  • Tracking and archiving of related documentation.

Post-marketing pharmacovigilance

  • Handling spontaneous reporting;

  • Submitting of ICSRs (Individual Case Safety Reports);

  • Performing the Local literature (non-index literature) screening and MLM literature (Index-literature);

  • Monitoring of Competent Authorities Websites;

  • Tracking and archiving of related documentation.

Phytovigilance

  • Safety Management Plan (SMP) drafting;

  • Handling of SAEs (Serious Adverse Events) and related queries;

  • Tracking and archiving of related documentation.

Other activities

  • Collaborating with Data Managers and IT team in order to finalize the Safety tool integrated the eCRF;

  • Managing of compassionate use program;

  • Management of the documentation required for customs clearance of the drug;

  • Manage drug resupply for Investigator Initiated Studies (IIT);

  • Participating to Advisory Board;

  • Escalating to the line manager in case of issues when necessary;

  • Joining Unit and company internal meetings;

  • Interacting with third parties as requested

Medical Device vigilance

  • Drafting Safety Management Plan (SMP) for clinical investigation;

  • Handling Safety reporting for clinical investigation (pre or post-marketing);

  • Handling ADE (Adverse Device deficiency), SADE (Serious Adverse Device deficiency), USADE (Unexpected Serious Adverse Device Deficiency), incidents;

  • Tracking and archiving of related documentation;

For further information please contact Louise on +44 (0)1293 584300

Salary: On application