Drug Safety Officer
Oracle
- Colombes, Hauts-de-Seine
- CDI
- Temps-plein
- Detect the combinations of questions & answers which could trigger a PV event to report in the studies.
- Evaluate the pharmacovigilance risk of the questionnaires administered to respondents (healthcare professional, patients…).
- Assess studies feasibility in terms of PV reporting.
- Participate in organizing and providing PV trainings to internal and external stakeholders.
- Implementing pharmacovigilance reporting process for studies.
- Writing of instructions to interviewers/moderators to ensure correct events are reported within the timelines.
- Ensure follow-up information requests (from the MAH) are fulfilled.
- Test automated systems to identify AEs/PV data generated from the online studies (ensure events are correctly spotted).
- Know and maintain the workflow and deadlines for each project.
- Review of notebooks received daily to detect potential adverse events.
- Filling in and sending adverse event forms to meet deadline and in accordance with legal requirements.
- Perform and coordinate reconciliation and source data PV verification.
- Ensure the filing and archiving of files in accordance with local, global, and European regulations for the pharmacovigilance requirements.
- Create and maintain dashboards.
- Maintain standard procedures for ongoing activities.
- Actively participate to the client audits.
- Ability to identify and author CAPA.
- Candidate will not perform signal detection, aggregate reports writing, and will not enter enter ICSRs into safety database.
- Pharmacy degree, Pharm. D.
- Minimum of 1 year of experience in Pharmacovigilance;
- Fluency in English and French (C1); both will be used on a daily basis;
- Excellent communication skills - able to distill issues, manage client expectations and act as a trusted advisor in a timely manner;
- Ability to multitask and work under-pressure with tight deadlines;
- Ability to prioritize;
- Excellent organization skills and attention to detail;
- Excellent IT skills (Pack Office).
- Which includes being a United States Affirmative Action Employer