Pharmacovigilance Coordinator

hace 4 días


Colonia Polanco, México UCB A tiempo completo

We are looking for a Pharmacovigilance Coordinator who is Responsible, self-management, detail-oriented, results-oriented, sense of urgency to join us in our team, based in CDMX
About the role
Accountable for ensuring Pharmacovigilance systems, operations and procedures are in place within the local
organization for all territories assigned to the affiliate.
What you’ll do
**Responsible for supporting the area of Pharmacovigilance**: Incoming ICSRs: support and close collaboration with external vendor regarding ICSRs processing (i.e. Quality checks, preparation and performing of trainings, exchange of feedback, processing of follow-up) and reconciliation processes, literature screening.
Coordinate translations of documents in local language of different sources (i.e. literature article, agreements or other safety related documents)
Support the implementation of compliance standards and collection of compliance metrics
Support the development and maintenance of local PV sops / sop-ai and forms
Support of performance and performance regular gap analysis as needed in order to ensure alignment with global PV sops/ sop-ai and forms
Supporting in preparation of PSURs, safety reports in Mexico and Risk Management Plans Risks (RMPs).
Performing monthly QC to PV processes (case intake, HA submission, FU, Literature review)
**MRP and Digital initiatives**: support of performing Quality checks, review of content if needed, maintenance of respective database with focus to PV relevant content/aspects and reconciliation.
**PSP, Registries and NIS**: support of any safety related activities regarding the mentioned projects
Interested? For this role we’re looking for the following education, experience and skills
**Education**: Health professional (Doctor, nurse, nutrition, QFB, Biomedical Engineering or similar)
**Language Skills**: Advanced English
**Experience**: 1 year in pharmacovigilance as an analyst or specialist, case processing.
**Software**: Argus, office
UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.