Senior PV Signal Detection Leader

Barrington James; España; Presencial; EUR 80.000 - 120.000; Jornada completa

Descripción de la vacante

Barrington James is seeking a Senior Pharmacovigilance professional to lead signal detection and evaluation across assigned portfolios in line with EMA GVP IX, ICH, FDA requirements. You will coordinate quantitative analyses (PRR, ROR, EBGM) on spontaneous reporting databases and perform qualitative assessments by integrating diverse data sources.

You will prepare signal detection and evaluation reports, ensure timelines, and oversee systematic literature reviews (Embase, PubMed).

Formación

• Advanced degree in pharmacy, medicine, life sciences, or epidemiology.
• Postgraduate qualification in pharmacoepidemiology or drug safety is advantageous.
• Minimum of 4 years’ experience in pharmacovigilance, with focus on signal detection.

Responsabilidades

• Lead design, execution, and oversight of signal detection activities using quantitative analyses.
• Conduct qualitative signal evaluation integrating multiple data sources.
• Prepare and review signal reports and management plans per SOPs and regulatory expectations.
• Ensure timely signal management reporting to EMA, FDA, and MHRA.
• Oversee literature searches (Embase, PubMed) and triage results for relevance.

Conocimientos

Signal detection methodologies

Regulatory safety databases

Data interpretation

Collaboration with stakeholders

Educación

PharmD or MD or life sciences degree

Postgraduate pharmacoepidemiology or drug safety

Herramientas

FAERS

EudraVigilance

VigiBase

Embase

PubMed

Oracle Argus Safety

ArisG LifeSphere

Veeva Safety

AB Cube SafetyEasy

Descripción del empleo

Barrington James is seeking a Senior Pharmacovigilance professional to lead signal detection and evaluation across assigned portfolios in line with EMA GVP IX, ICH, FDA requirements. You will coordinate quantitative analyses (PRR, ROR, EBGM) on spontaneous reporting databases and perform qualitative assessments by integrating diverse data sources.

You will prepare signal detection and evaluation reports, ensure timelines, and oversee systematic literature reviews (Embase, PubMed).