- 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 integral 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 an

📌 Pv Signal Detection Lead (La Mancha)
🏢 Barrington James
📍 La Mancha