For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D; technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.The Senior Pharmacovigilance (PV) Scientist supports the activities in the Benefit Risk group by ensuring that day to day operational activities is completed. The Senior PV Safety Scientist is expected to be professional and diligent and liaises with the director and management group members within the team on any issues, as well as coordinate the work performed by PV Scientists.



The Senior PV Safety Scientist is also expected to lead by example and ensures quality standards are upheld within the company.Job responsibilitiesAuthoring and Quality review of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR) for submission to local and other Health Authorities.Authoring and review of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities.Authoring and Quality review of Signal Management Reports.Performing literature search and validity check for the aggregate reports.Management and reconciliation of relevant process trackers.Subject matter expert (SME) along with training and mentoring of individuals.Extraction and validation of data (RSI, Sales, previous reports, RMP, signals).Generation of Line Listings (LL) from safety database and Quality check of the line listings when requiredProviding reliable support for high priority Ad-

📌 Senior Pharmacovigilance Safety Scientist, Benefit Risk (España)
🏢 Propharma Group
📍 España