PV Signal Detection Lead

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

• Senior-level Pharmacovigilance (PV) professional responsible for leading and executing signal detection and evaluation activities across assigned portfolios.
• Combines scientific and epidemiological expertise with operational oversight of signal management workflows to ensure emerging safety signals are identified, assessed, prioritised, and communicated in line with global regulatory requirements (e.g., EMA GVP Module IX, ICH, E2E, FDA) and client procedures.
• Acts as the subject matter expert for signal-related activities and collaborates closely with medical reviewers, project leads, and client stakeholders.

Responsibilities

• Lead the design, execution, and oversight of signal detection activities, including quantitative analyses (e.g., PRR, ROR, EBGM) applied to spontaneous reporting databases (e.g., FAERS, EudraVigilance, VigiBase).
• Conduct qualitative signal evaluation by integrating data from spontaneous reports, clinical trials, post-authorisation safety studies, scientific literature, and social media monitoring where applicable.
• Prepare and review signal detection reports, signal evaluation reports, and signal management plans in line with client SOPs and regulatory expectations.
• Ensure signal management activities are completed and reported within required regulatory timelines to relevant authorities (e.g., EMA, FDA, UK MHRA).
• Oversee systematic medical literature searches (e.g., Embase, PubMed) and supervise the triage and assessment of results for signal-relevant publications and individual case reports.

Requirements

• Advanced degree in pharmacy (PharmD preferred), medicine, life sciences, or epidemiology; a postgraduate qualification in pharmacoepidemiology or drug safety is advantageous.
• Minimum of 4 years’ experience in pharmacovigilance, with at least 2 years focused on signal detection or pharmacoepidemiology within a PV vendor, CRO, or pharmaceutical company environment.
• Hands‑on experience with signal detection methodologies and regulatory safety databases (e.g., FAERS, EudraVigilance, VigiBase) is required.
• Proficiency with safety databases (e.g., Oracle Argus Safety, ArisG LifeSphere, Veeva Safety, AB Cube SafetyEasy), signal detection tools, and literature databases (Embase, PubMed), plus Microsoft Office Suite; familiarity with statistical tools is an advantage.