Pharmacovigilance Specialist

Location
Spain
Salary
Competitive salary based on experience
Posted
23 Apr 2021
Closes
23 May 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Entry level

Pharmacovigilance / Drug Safety Specialist – medical devices

Location - 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. 

The Pharmacovigilance /PV Specialist, 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;

You will have ideally graduated in a scientific field with at least 1 years’ experience within Pharmacovigilance / Drug safety.  Candidates must have previous experience working for a CRO and ideally worked in PV with medical devices.

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

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