Pharmacovigilance Specialist - UK

Location
United Kingdom (GB)
Salary
Competitive salary based on experience
Posted
23 Apr 2021
Closes
23 May 2021
Ref
21544
Hours
Full Time
Contract Type
Permanent
Experience Level
Graduate

Pharmacovigilance Specialist – medical devices

Location - UK (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 in a science related subject 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