Pharmacovigilance Specialist - Spain
- Employer
- RBW Consulting
- Location
- Spain
- Salary
- Competitive salary based on experience
- Start date
- 23 Apr 2021
- Closing date
- 23 May 2021
View more
- Discipline
- Clinical Research, Drug Safety, Pharmacovigilance
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Entry level
Job Details
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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